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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned, the evaluation is in progress.
Event or Problem Description
It was reported that during an angiogram of the leg, the wire became stuck on another manufacturer's atherectomy device.When pulling the wire out, a piece of the flexor high-flex ansel guiding sheath was broken off and came out on the wire.No fragments remained within the patient.No additional details have been received.
Additional Manufacturer Narrative
Evaluation- a review of the complaint history, device history record, quality control, trends, and a visual inspection were conducted during the investigation of this event.A kcfw-7.0-35-55-rb-hfanl0-hc sheath was returned for investigation along with a detached 5 cm segment of tnrt liner.No other damage was observed to the sheath tubing.The device history records were reviewed for the final product lot 6652218 and no non-conformances were noted.A search of the complaint handling database revealed no other complaints of this nature associated with lot 6652218.The other manufacturer's device used through the kcfw-7.0-35-55-rb-hfanl0-hc sheath in the described procedure has a front cutting element at the distal tip.The wire being used through the sheath to advance the other manufacturer's device was identified as a non-cook wire.The non-cook wire was inserted into the sheath, but not the kcfw-7.0-35-55-rb-hfanl0-hc supplied dilator.It is reported that no part of the device remained in the patient; the patient had no adverse effects, and required no additional procedures.It is possible that the inner lining of the sheath could have been torn by the other manufacturer's device (either during insertion or removal); the inner lining then could have gotten caught on the wire as it was being removed.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

• 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: 6335229
• Report Number: 1820334-2017-00187
• Device Sequence Number: 1021524
• Product Code: DYB
• UDI-Device Identifier: 00827002562325
• UDI-Public: (01)00827002562325(17)190127(10)6652218
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-7.0-35-55-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1