MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-04-27 for SPYSCOPE ACCESS AND DELIVERY CATHETER M00546230 4623 manufactured by Boston Scientific - Marlborough.
[1948211]
Note: this report pertains to one of two devices used during the same procedure. Manufacturer report # 3005099803-2011-01371 addresses the other device. It was reported to boston scientific corporation that a spyscope access and delivery catheter and spyglass direct visualization probe were used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6), 2011. According to the complaint, during the procedure the spyscope split lengthwise, but remained in one piece. Additionally, the spyglass probe which was within the spyscope broke into two pieces. No part of the spyglass probe detached into the patient. The case was completed with another spyscope access and delivery catheter and spyglass direct visualization probe. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be okay.
Patient Sequence No: 1, Text Type: D, B5
[1999571]
Note: this report pertains to one of two devices used during the same procedure. Manufacturer report # 3005099803-2011-01371 addresses the other device. It was reported to boston scientific corporation that a spyscope access and delivery catheter and spyglass direct visualization probe were used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6), 2011. According to the complaint, during the procedure the spyscope split lengthwise, but remained in one piece. Additionally, the spyglass probe which was within the spyscope broke into two pieces. No part of the spyglass probe detached into the patient. The case was completed with another spyscope access and delivery catheter and spyglass direct visualization probe. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be okay.
Patient Sequence No: 1, Text Type: D, B5
[9042496]
Although the suspect device has been received, the evaluation has not yet been completed. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[9050850]
A visual examination of the returned device revealed that the pebax was cut near the tip. The condition of the returned incident device was consistent with the complaint that the sheath was torn near the tip. The evaluation attributed this failure to the manufacturing process. Therefore, the most probable root cause is supplier manufacture. An investigation is underway to address this issue. A review of the device history record (dhr) was performed; no anomalies were noted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2011-01370 |
| MDR Report Key | 2070679 |
| Report Source | 05,07 |
| Date Received | 2011-04-27 |
| Date of Report | 2011-04-06 |
| Date of Event | 2011-04-05 |
| Date Mfgr Received | 2011-05-03 |
| Device Manufacturer Date | 2010-10-27 |
| Date Added to Maude | 2011-04-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMP. CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | MEDVENTURE TECHNOLOGY CORPORATION |
| Manufacturer Street | 2301 CENTENNIAL BOULEVARD |
| Manufacturer City | JEFFERSONVILLE IN 47130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYSCOPE ACCESS AND DELIVERY CATHETER |
| Generic Name | MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY |
| Product Code | ODF |
| Date Received | 2011-04-27 |
| Returned To Mfg | 2011-04-15 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| Lot Number | 1ML0100101 |
| Device Expiration Date | 2011-10-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-27 |