MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-26 for SPYSCOPE DS 4660 manufactured by Boston Scientific Corporation.
[137244437]
Date of event was approximated to be (b)(6) 2019 as no event date was reported. A visual assessment was performed. The catheter demonstrated signs of use. As received, the working channel sleeve (wcs) protruded. Maximum wcs protrusion was observed when the distal tip was articulated by turning the large knob in both directions. Upon plugging the device into the controller, it displayed a live, clear image. No issues were identified with the image. The device was fully articulated in all directions; no issues were identified with the image. A guidewire was inserted through the working channel port and passed through the working channel; no issues were identified with the image. A spybite was passed though the working channel; no issues were identified with the image and no issues were identified when passing an accessory through the working channel sleeve. The distal tip was cut. The distal cap was removed. The catheter was cut open using the cutting fixture. The working channel sleeve was removed. Witness marks were noted on the pebax. The white and clear areas along bond a appeared to show evidence of adhesion. It was found during the investigation of the returned spyscope ds that the working channel sleeve was protruding. Based on investigation results, the underlying cause of working channel sleeve protrusion is an insufficient bond, particularly the second heat cycle of the working channel sleeve bonding process [bond b]. Working channel sleeve protrusion in devices manufactured post 01mar2018 changes has been determined to be a design issue, therefore, the complaint investigation conclusion code selected for the working channel sleeve protrusion issue is design inadequate for purpose, which indicates that problems were traced to design/design features of the device that do not support or do interfere with the intended purpose of the device. An investigation is underway to address this issue. A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint. The dhr review confirms that the accepted device met all manufacturing specifications.
Patient Sequence No: 1, Text Type: N, H10
[137244438]
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was returned in a biohazard bag. There is no further information regarding this event. This event has been deemed reportable based on the investigation results; working channel sleeve protruded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00940 |
| MDR Report Key | 8372246 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-02-06 |
| Device Manufacturer Date | 2018-07-24 |
| Date Added to Maude | 2019-02-26 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYSCOPE DS |
| Generic Name | CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
| Product Code | FBN |
| Date Received | 2019-02-26 |
| Returned To Mfg | 2018-12-28 |
| Model Number | 4660 |
| Catalog Number | 4660 |
| Lot Number | 22422150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-26 |