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	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A flexor high-flex ansel guiding sheath was used in cardiac catheterization for occlusion of coronary fistula under general anesthesia.It was reported that, the flexor check-flo introducer was inserted into the patient via the pre-existing 5fr femoral artery sheath along a 0.018 platinum plus guidewire.The sheath position was assessed to be satisfactory.Some resistance was noted on trial of advancing the vascular plug across the valve of the flexor check-flo introducer, hence the valve was pre-dilated gently with a 5fr dilator before reintroducing the vascular plug.However, upon advancement of the vascular plug across the valve, the shaft of the flexor check-flo introducer was noted to have broken off from the hub and the shaft was noted to have embolized (with the distal segment still in the right coronary fistula, a loop of the introducer into the left ventricle while the proximal end tip was at the right external iliac artery).Additional information has been requested, but has not yet been received.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One used flexor high-flex ansel guiding sheath was returned for examination.Kinks are noted at 1.0 cm, 38.9 cm, 43.8 cm, and 48.8 cm from the proximal end.Compressions are noted at 2.0 cm and 49.7 cm from the proximal end.Coil is exposed at the proximal end.Coil is 1.7 cm in length.The connector was disassembled from the check-flo body to further examine the flared material retained in the proximal fitting.Separated section (proximal end) with flare is 2 mm in length.The length of the catheter and the inner diameter of the connector cap measure within specifications.The flare on the proximal end was tested and also passed specifications.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events.A review of the subassembly device history records were reviewed and two non-conformances were noted; however, all non-conforming product was scrapped prior to completion of the final lot.It should be noted there were no other reported complaints for this lot number.Per the ifu: warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Precautions: do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Based on the information provided, examination of the returned product, and the results of our investigation; the root cause was determined to be user technique.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.
Additional Manufacturer Narrative
An amplatzer vascular plug ii was being utilized through the sheath.The sheath was inserted via the right femoral artery (distal position in right coronary fistula).The separation occurred during insertion of the device.The patients anatomy was not calcified but the fistula was slightly tortuous.

• 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: 6880268
• Report Number: 1820334-2017-03192
• Device Sequence Number: 16174255
• Product Code: DYB
• UDI-Device Identifier: 00827002562349
• UDI-Public: (01)00827002562349(17)200718(10)NS8074064
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2018

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: KCFW-4.0-35-55-RB-HFANL1-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 10/03/2017; 12/27/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 10/10/2017; 01/09/2018
• Patient Sequence Number: 1