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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Kinked (1339); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
Information was provided that during a lower leg arterial angioplasty procedure on the male patient, the sheath kinked.The sheath was in the left femoral artery and it was up and over the bifurcation.At the end of the procedure, the physician was removing the sheath over another manufacturer's wire and the physician felt a resistance and a slight pop.The sheath was released and removed without any further complications.However, the sheath was kinked and had a small pin hole at the kink site.The physician unbent the sheath for examination and the sheath broke in two pieces.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), 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: "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.If using an introducer with aq hydrophilic coating, activate hydrophilic coating by wetting the outer surface of the device with heparinized saline.Note: for best results, maintain wetted condition of device during placement." the visual inspection of the returned device reported one used/damaged kcfw-5.0-35-70-rb-hfanl0-hc sheath was returned for investigation with the sheath completely separated into 2 segments.The separation was measured to occur 26.3 cm from the proximal end.At the separation site, the edge of the proximal segment tubing was out of round and slightly flattened.The event description stated that the separation of the sheath tubing occurred outside the patient when the physician was examining the device.It is possible that calcification caused the resistance felt during removal of the device and contributed to damaging the device.It was noted that only the corits stork wire was inserted in the sheath at the time of removal; not having an inserted dilator (as stated in the ifu) could have also contributed to the reported failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
Information was provided that during a lower leg arterial angioplasty procedure on the male patient, the sheath kinked.The sheath was in the left femoral artery and it was up and over the bifurcation.At the end of the procedure, the physician was removing the sheath over another manufacturer's wire and the physician felt a resistance and a slight pop.The sheath was released and removed without any further complications.However, the sheath was kinked and had a small pin hole at the kink site.The physician unbent the sheath for examination and the sheath broke in two pieces.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• 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: 6000777
• Report Number: 1820334-2016-01018
• Device Sequence Number: 1897088
• Product Code: DYB
• UDI-Device Identifier: 00827002562202
• UDI-Public: (01)00827002562202(17)190617(10)7052004
• 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: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2016

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-5.0-35-70-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1