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	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: "precautions: the maximum diameter of the instrument or catheter to be introduced should be determined to ensure its passage through the introducer.All instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight.When inserting, manipulating, or withdrawing a device through an introducer always maintain introducer position.When inflating a balloon at, or close to, the introducer tip, ensure the balloon is not inside the distal tip of the introducer.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." it should be noted there were no other reported complaints for this lot number.The visual inspection of the returned device reported one used kcfw-5.0-35-55-rb-hfanl0-hc sheath and segment of detached tnrt lining (approximately 50 cm) was returned for investigation.A section of the sheath was wrapped in what appeared to be medical tape.There was no apparent damage to the sheath tubing which was wrapped.The distal tip of the sheath was found to be slightly out of round.An endoscope was used to view the interior of the sheath.The tear in the tnrt lining was found to start approximately 1 cm from the proximal end and continued to the distal end of the sheath.Also, the tear was found to be thinner at the proximal end.The resistance encountered when trying to remove the balloon could be attributed to the balloon not being fully deflated and/or the sheath delaminating could have caused the balloon to get caught.It is possible that a device used in conjunction with the sheath could have tore part of the inner lining, which then would have led to the reported failure mode.However, a definitive root cause cannot be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
The flexor high-flex ansel guiding sheath was advanced and another manufacturer¿s balloon was used/inflated.A lot of resistance was made in attempting to remove the balloon.Per the dm, ¿they pulled so hard, i did not think they were going to get the balloon out.¿ the physician was finally able to remove the balloon and sheath and exchanged with another small non cook 4 fr sheath.The wire was removed through the sheath and at that time it was noted that the lining from the first sheath was entangled with the wire.All was removed from the patient with no adverse effects.

• 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: 6137616
• Report Number: 1820334-2016-01423
• Device Sequence Number: 1075289
• Product Code: DYB
• UDI-Device Identifier: 00827002562301
• UDI-Public: (01)00827002562301(17)190819(10)7211905
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2016

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-5.0-35-55-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2016
• Initial Report FDA Received Date: 12/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1