MAUDE Adverse Event Report: COOK INC FLEXOR SHUTTLE TIBIAL 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	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported device is not available for evaluation.The event is currently under investigation.
Event or Problem Description
A flexor shuttle tibial guiding sheath was used during an unspecified procedure.It was reported that the fellow pulled the sheath out of the patient by the side arm and the adaptor "popped off" the sheath at the hub (event captured in medwatch with manufacturer report number 1820334-2017-02319).Additionally, the physician stated that it "happens all the time" although this is the first time the rep has witnessed and/or heard of it (event captured in medwatch with manufacturer report number 1820334-2017-02485).No unintended section of the device remained inside of the patient's body and there were no adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Received 8/8/2017: the sheath was placed in the right groin.Access was gained via contralateral approach- no extreme tortuosity or tight bifurcation.A wire was inserted into the sheath prior to removal; however the sheath separation was at the hub and no coiling was shown.Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.Only the used sheath and the tuohy-borst adapter of the flexor shuttle tibial guiding sheath were returned.The sheath was returned with no connector cap present.The flare of the sheath passed through the large lumen of the flare gauge but did not pass through the small hole.The flare was out of round, with slight waving present.The flare of the sheath did pass through the large lumen of the flare gauge and did not pass through the small lumen.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 available information, examination of the returned device and investigation results, it is possible the user's technique during removal from the body contributed to this event, since the sheath was pulled by the side-arm which could have caused the adaptor to pop of the hub.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 SHUTTLE TIBIAL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6785465
• Report Number: 1820334-2017-02319
• Device Sequence Number: 1116148
• Product Code: DYB
• UDI-Device Identifier: 00827002132641
• UDI-Public: (01)00827002132641(17)200313(10)7744786
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 08/10/2017
• 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
• Patient Age: 63 YR