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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported, at the end of a procedure upon removal, the sheath became stuck and would not come out.An attempt was made to reinsert the dilator to remove the sheath, which did not work.The staff made another attempt at removal by placing a balloon in the sheath, this also did not work.Eventually the sheath was removed but was reportedly in bad shape.The patient was unharmed and no additional procedures were required.No additional details have been received at this time.
Additional Manufacturer Narrative
A review of the complaint history, device history record, documentation, instructions for use (ifu), quality control, specifications, and visual inspection of the returned device was conducted during the investigation.The physician is provided with an ifu (instructions for use), which states, "warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Sheath removal: insert wire guide at least 10cm past the tip of the sheath.Insert the dilator over the wire into the sheath.Withdraw the sheath and dilator as a unit.Remove the wire guide." the sheath was returned with the sheath tubing in three segments.The most distal section was completely separated.The two more proximal sections were connected by intact coiling.There was also a piece of detached coiling returned with tnrt liner embedded within the coil.The tubing was frayed at the separation sites and showed signs of elongation.A slight kink was observed at the second bond site (from the distal end.) the overall length of the tubing sections was 70.6 cm a search of the complaint database revealed this complaint to be the only reported complaint associated to the complaint lot number 7461035.The device history record was reviewed and one nonconformance was noted.The nonconformance listed on the device history record was for loose foreign matter.This nonconformance is not related to the reported failure.The device history record for the subassembly lot was also reviewed and no nonconformances were noted.It is possible that this event is related to the reported tortuosity and calcification or the patient¿s anatomy.No adverse effect was observed on the patient.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: 6304991
• Report Number: 1820334-2017-00183
• Device Sequence Number: 19028371
• Product Code: DYB
• UDI-Device Identifier: 00827002562219
• UDI-Public: (01)00827002562219(17)191121(10)7461035
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2017

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-6.0-35-70-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1