MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-03-13 for RICHARD ALLAN VESSEL LOOP MAXI YELLOW NON-STERILE 390490 manufactured by Aspen Surgical Products, Caledonia.
[138696105]
Aspen surgical received a report from the distributor indicating that the end user alleged that the yellow vessel loop broke while in the groin during a procedure. A manufacturing lot number was provided for evaluation. No sample was available for return. According to the end user, after completion of an axillary bifemoral bypass procedure on (b)(6) 2019, the surgeon intentionally stapled both groin incisions with a vessel loop hanging out of each groin incision. On (b)(6) 2019, it was noted that the loop had completely ripped off on the left side and a piece of the loop remained inside the patient. The incision was reopened, and the piece of loop successfully retrieved. It was also noted that the right loop was ripped but remained intact. The customer also reported the patient has since expired. The end user declined to provide any further details regarding the patient's medical history, use of the loop, and the patient? S death. The vessel loop instructions for use include the following - for one time use in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures. After removing loops from package, the surgeon may do as follows: retract-wrap around vessel. Clamp loop to drape or hang outside wound. Occluding-wrap around vessel twice. Clamp adjacent to vessel to secure. Identify-wrap loop around vessel, nerve and ureter or intestine. At end of procedure, dispose of loop in an appropriate manner. Precaution: vessel loops are single use only. Reuse of this device may lead to patient cross contamination. Device is intended for limited contact duration, less than or equal to 24 hours. The vessel loops were used to buttress suturing, which is outside of the intended use. The broken vessel loop required surgical intervention (reopening of the incision) to retrieve the broken piece. No additional information related to the patient was provided. The date of death and cause of death is unknown and therefore can not be attributed to the use of the loop. Additionally, a review of the device history record was completed. No non-conformance's were noted relating to the reported issue. Due to having no sample available for return, no further information is available. Reported issue could not be confirmed. Based on the information provided, no further actions are required.
Patient Sequence No: 1, Text Type: N, H10
[138696106]
Aspen surgical received a report from the distributor indicating that a vessel loop broke while in use during a procedure. Event occurred at the end user. This report was filed in our complaint handling system as number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2019-00022 |
| MDR Report Key | 8417243 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-03-13 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-05-10 |
| Date Added to Maude | 2019-03-13 |
| 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 | MR. JORDAN HACKERT |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6165367508 |
| Manufacturer G1 | SAME AS ABOVE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RICHARD ALLAN VESSEL LOOP MAXI YELLOW NON-STERILE |
| Generic Name | VESSEL LOOP |
| Product Code | KDC |
| Date Received | 2019-03-13 |
| Model Number | 390490 |
| Lot Number | 163816 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-03-13 |