MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-08 for FLEXOR ANSEL GUIDING SHEATH N/A KCFW-8.0-18/38-45-RB-ANL1-HC manufactured by Cook Inc.
[77309827]
(b)(4). A review of the complaint history, drawings, device history record, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation. A used, damaged flexor ansel guiding sheath was returned and examined. Biomatter was present. The distal tip of the sheath tubing was curled, stretched, and had hangnail damage. The device was confirmed to have the correct type and length of sheath tubing on the distal portion of the sheath. Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode. There were no other reported complaints for this lot number. Based on the information provided and the results of our investigation, a definitive root cause could not be determined at this time. Per the risk assessment, no further action is warranted at this time. Monitoring will continue to be performed for similar complaints. The damage displayed on the returned device for this complaint, indicates that user technique likely contributed to the failure mode of the complaint device.
Patient Sequence No: 1, Text Type: N, H10
[77309828]
During the investigation is was determined that the distal tip of the flexor ansel guiding sheath tubing was curled, stretched, and had hangnail damage. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-01237 |
| MDR Report Key | 6623593 |
| Date Received | 2017-06-08 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-04-21 |
| Date Mfgr Received | 2017-07-07 |
| Device Manufacturer Date | 2016-10-20 |
| Date Added to Maude | 2017-06-08 |
| 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. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLEXOR ANSEL GUIDING SHEATH |
| Product Code | GCC |
| Date Received | 2017-06-08 |
| Model Number | N/A |
| Catalog Number | KCFW-8.0-18/38-45-RB-ANL1-HC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-08 |