MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation: a review of the complaint history, device history record, ifu, quality control and visual inspection of the returned device was conducted.A used/damaged sheath was returned on 29dec2016 to assist with the investigation.It was noted that the sheath tubing flattened starting 2.8 cm from the distal tip and continuing proximally for 19.5 cm.The proximal hub and a small proximal section of the sheath tubing were separated from the remaining length of the sheath tubing.The separated distal tubing segment showed slight fraying at the separation site, while the proximal tubing segment did not appear to be frayed at the separation site.Additionally, the coiling within the sheath tubing at the separation site did not appear to be stretched.This material separation was not reported along with reported issue.This condition was additionally noted during the visual inspection of the returned device.The tubing did not appear to be stretched.This condition is possibly indicative of manipulation to the device during removal.No events related to the reported issue were found during a review of related manufacturing or quality records.Review of the associated device history record did not identify non-conformances that may be related to this reported incident.No similar complaints have been reported for this lot number.There is no evidence to suggest that the device was not manufactured to specification.Vascular intervention was being performed on the popliteal / tibial arteries to treat the patient's peripheral vascular disease (pvd).It is likely that the j wire could not be advanced into the sheath because a portion of the sheath tubing became flattened during the procedure.It is possible that a build up of plaque could have caused the sheath to flatten without the added support from a dilator, catheter, etc.Also, it is possible that an artery spasm could have occurred, thus causing the sheath to flatten.
Event or Problem Description
It was reported, during vascular intervention of the popliteal / tibial arteries, a flexor sheath became stuck inside the body and a j wire was unable to be passed through the device.The sheath was retrieved from the patient through manipulation performed by the physician.Once removed, the sheath was found to be "flattened and the lumen was not patent." the patient returned 3 days later for antegrade approach to complete the original procedure.There was no reported harm to the patient.No additional details have been received.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6266041
• Report Number: 1820334-2017-00055
• Device Sequence Number: 830857
• Product Code: DYB
• UDI-Device Identifier: 00827002562349
• UDI-Public: (01)00827002562349(17)190930(10)7319736
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-4.0-35-55-RB-HFANL1-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2016
• Initial Report FDA Received Date: 01/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR