MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-23 for FIXT SUTURING DEVICE SD100 manufactured by Bard Shannon Limited -3005636544.
[45756312]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Device discarded.
Patient Sequence No: 1, Text Type: N, H10
[45756313]
It was reported that after identification of the suture passage site on the right sacrospinous ligament, the device was applied on that site in order to pass that anatomical structure. The fixing mechanism was activated and on release there was no complete passage of the suture through the ligament. The rupture of the suture occurred by means of the same deploying mechanism, with consequent permanence of the metallic cuneiform section of the suture on the ligament. That metallic wedge was carefully removed by the sacrospinous ligament after various manipulations that caused major bleeding, exposing the patient to further potential intra-operative risks.
Patient Sequence No: 1, Text Type: D, B5
[46479583]
The device was not returned for evaluation. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "device description the fixt? Suturing device is a device designed as an aid for the placement of sutures during pelvic floor surgery. Indications for use: the fixt? Suturing device is intended for use in general suturing applications to assist in the placement of suture material in tissues at the operative site. Contraindications: the fixt? Suturing device is contraindicated for placing sutures into or through bone. Warnings: the instrumentation associated with the placement of suture material can carry an inherent risk of bleeding. Use only needles and suture specified for use with the fixt? Suturing device. After use, the product and its packaging should be treated as a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. Precautions: the fixt? Suturing device has not been evaluated in human subjects; based on physician experience and training, a thorough assessment of each patient should be made to determine their suitability for the procedure. Consideration should also be given to the ability of the patient to tolerate the surgical procedure; the fixt? Suturing device should only be used with size 0 fixt? Sutures with fx45 needles; when loading an fx45 needle into the fixt? Suturing device, ensure that the tip of the needle does not protrude from the needle deployment mechanism; do not place excessive counter-traction on the suture material, as this may result in interference with the deployment mechanism and may damage the suture material; once the suturing mechanism has been activated, continue depressing the handle until the needle has been fully deployed. Stopping mid-stitch may dislodge the needle from the deployment mechanism and cause an inadequate transfer of the needle to the capture mechanism; once the suturing mechanism has been activated, do not rotate or torque the fixt? Suturing device, as this may result in patient injury; the fixt? Suturing device is provided sterile inside a holding tray within an outer box. The holding tray is not sterile and may not be placed in the sterile field. Transfer the device to the sterile field using aseptic techniques; check the integrity of the packaging before use. Do not use the device if the packaging is opened or damaged; as for any sterile surgical instrumentation, it is recommended to open the tray at the time of use; the fixt? Suturing device is intended as a single-patient use device. Do not resterilize any portion of the fixt? Suturing device. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient. Adverse events: potential complications associated with the proper usage of the fixt? Suturing device may include, but are not limited to: bleeding; hematoma; infection; injury to internal vessels and nerves; injury to internal organs and tissue including perforation and occlusion; inflammatory reaction to suture material or the trauma of being sutured. Directions for use: connect the stainless steel needle point of the appropriate suture into the needle deployment mechanism. Support the suture throughout the procedure; position the distal head of the device in the desired location for suturing; while applying digital pressure against the ridges on the head of the device, completely depress the trigger mechanism to deliver the suture through the desired tissues. The device will capture the needle point on the other side of the tissues; release the trigger mechanism to allow the needle deployment mechanism to return to its original position. As the device is withdrawn from the surgical site, the captured suture will be withdrawn along with it; remove the needle point from the catchment mechanism by depressing the button on the underside of the device head; suture knots may now be tied down to complete the procedure; ensure that needle tips are removed and disposed of in appropriate sharps containers. Note: as required, the distal head of the fixt? Suturing device may be rinsed intraoperatively in a bowl of sterile saline to remove tissue debris. " (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2016-00680 |
| MDR Report Key | 5673905 |
| Date Received | 2016-05-23 |
| Date of Report | 2016-05-23 |
| Date of Event | 2016-04-01 |
| Date Mfgr Received | 2016-05-23 |
| Device Manufacturer Date | 2015-12-19 |
| Date Added to Maude | 2016-05-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JANNA PARKS |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | BARD SHANNON LIMITED -3005636544 |
| Manufacturer Street | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 |
| Manufacturer City | HUMACAO PR 00791 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXT SUTURING DEVICE |
| Generic Name | SUTURING DEVICE |
| Product Code | GDF |
| Date Received | 2016-05-23 |
| Catalog Number | SD100 |
| Lot Number | HUZK1831 |
| Device Expiration Date | 2017-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD SHANNON LIMITED -3005636544 |
| Manufacturer Address | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 HUMACAO PR 00791 US 00791 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-23 |