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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2017
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 during an unspecified procedure.It was reported that the valve of the introducer was leaking while the wire was in place.The blood loss was reported to be "not very big".Additional information has been requested, but has not yet been received.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, 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 investigation.The dilator was also returned, but was not inserted into the sheath.The sheath was tested for leakage with the dilator inserted and not inserted.Leakage was detected at the silicone disc.The check-flo valve was disassembled to examine the silicone disc.The proximal slit on the disc was slightly off center and a 1 millimeter (mm) tear was present perpendicular to the proximal slit.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 that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per manufacturing instructions, flexor high-flex ansel guiding sheaths are inspected and it is visually verified that the slits are centered within the disc.Based on the information provided, examination of the returned product, and the results of our investigation, the root cause for the leakage was determined to be manufacturing related as the proximal slit on the disc was off center.Dilator insertion through the disc with the off center slit of the check-flo valve likely led to the tear on the proximal side of the disc, causing the check-flo valve to leak.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed 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: 6916150
• Report Number: 1820334-2017-03361
• Device Sequence Number: 1181626
• Product Code: DYB
• UDI-Device Identifier: 00827002477018
• UDI-Public: (01)00827002477018(17)180908(10)6184947
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 01/10/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-12.0-35-45-RB-HFANL1-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1