MAUDE Adverse Event Report: COOK INC FLEXOR INTRODUCER SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	09/05/2017
Type of Reportable Event	Serious Injury
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 introducer sheath was used in an atherectomy.It was reported that after the physician gained access with one sheath it was exchanged for the flexor sheath.The flexor sheath was used for the rest of the procedure and when it was pulled back through the ipsilateral side, the portion containing the valve snapped off.The physician used clamps to remove the sheath from the patients body.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any other adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, 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 and one unused flexor introducer sheath were returned.The used sheath was examined.A bend is present in the sheath tubing 2.8cm from the proximal end.A 4mm compression is present at 1.6cm from the proximal end.Two wrinkles were noted in the flare.The flare passes through the large lumen but does not pass through the small lumen of the flare gauge.The connector cap was removed for further examination and no non-conformities were noted.The connector cap accepted a maximum pin gauge, hence built to specification.A visual and physical inspection was performed for the unused device and no nonconformities were noted.The check-flo cap is secure and the device surface is free of excessive dents, bumps and scratches.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 would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Measures have been conducted to address this failure mode.The appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6855789
• Report Number: 1820334-2017-02911
• Device Sequence Number: 761988
• Product Code: DYB
• UDI-Device Identifier: 00827002098107
• UDI-Public: (01)00827002098107(17)200519(10)7927423
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-7.0-38-45-RB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 100