MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-27 for EVOLUTION? COLONIC CONTROLLED-RELEASE STENT - UNCOVERED G48028 EVO-25-30-8-C manufactured by Cook Ireland Ltd.
[137414650]
(b)(4). This complaint is linked to another file (b)(4) 3001845648-2019-00021 (broken flexor) as a second failure - kinked flexor was observed during the lab evaluation. Lab evaluation: the device involved in the complaint was evaluated in the laboratory on the 30th january 2019. Flexor was observed kinked. Documents review including ifu review: prior to distribution all evo-25-30-8-c devices are subjected to a visual inspection and functional checks to ensure device integrity. These inspections and functional checks are outlined in internal procedures in place at (b)(4). A review of the manufacturing records for evo-25-30-8-c device of lot number c1311877 did not reveal any discrepancies that could have contributed to this issue. Upon review of complaints, this failure mode has occurred previously with lot number c1311877. Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1311877. This complaint is linked to complaint file (b)(4) (broken flexor) as a second failure - kinked flexor was observed during the lab evaluation. A project was carried out to make improvements to the flexor design. The instructions for use ifu0052-10 which accompanies this device and instructs the user to ""visually inspect with particular attention to kinks, bends and breaks. If any abnormality is detected that would prohibit proper working condition, do not use". There is no evidence to suggest that the customer did not follow the instructions for use ifu0052-10. Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory. A possible root cause of kinked flexor could be attributed to transport returns. Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Complaint is confirmed as the failure was verified in the laboratory. Complaints of this nature will continue to be monitored for potential emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[137414651]
Flexor kinked observed during lab evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2019-00078 |
| MDR Report Key | 8373358 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-27 |
| Date of Report | 2019-01-30 |
| Date of Event | 2018-12-12 |
| Date Facility Aware | 2019-02-27 |
| Date Mfgr Received | 2019-01-30 |
| Device Manufacturer Date | 2017-01-06 |
| Date Added to Maude | 2019-02-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. HEATHER RYAN |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Manufacturer Phone | 061334440 |
| Manufacturer G1 | COOK IRELAND LTD |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVOLUTION? COLONIC CONTROLLED-RELEASE STENT - UNCOVERED |
| Generic Name | MQR STENT, COLONIC METALLIC EXPANDABLE |
| Product Code | MQR |
| Date Received | 2019-02-27 |
| Returned To Mfg | 2019-01-29 |
| Model Number | G48028 |
| Catalog Number | EVO-25-30-8-C |
| Lot Number | C1311877 |
| Device Expiration Date | 2019-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 705 DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK IRELAND LTD |
| Manufacturer Address | O HALLORAN ROAD LIMERICK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-27 |