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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
It is alleged that a flexor raabe guiding sheath was being used for a left-leg angio for the tibials when the sheath separated.It was reported that as the sheath was being exchanged at the end of the case, the "check-flo" came out but the remainder of the sheath was left in the patient.The complainant continues that the patient required an additional surgery for removal, which was deemed successful as the device was removed and the initial procedure was completed.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One used flexor raabe guiding sheath and dilator were returned for evaluation.Sheath was returned damaged and separated into 4 sections.The proximal section (hub attached) measured 27.7cm, and a kink was noted at 11.0cm from the proximal end.The distal section measured 49.5cm.Compressions were noted at 13.7cm, 19.4cm, 22.1cm, 23.6cm, 25.0cm and 26.0cm from the proximal end.Coil wire is protruding 3.0cm from proximal end.A separate coil wire measured 37.0cm.A second coil wire was 21.0cm.Delamination was attached to the second coil wire and was 10.0cm in length.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.Per the instructions for use (ifu), t_intro_rev2, states, "warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Based on the available information and examination of the complaint device, it is likely that the event can be attributed to the patient¿s clinical condition (somewhat tortuous, but not calcified anatomy), and/or the healthcare professional¿s technique/procedure (only the wire guide was inserted through the complaint sheath, but the dilator was not inserted during removal).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 RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6747118
• Report Number: 1820334-2017-02098
• Device Sequence Number: 1063444
• Product Code: DYB
• UDI-Device Identifier: 00827002130913
• UDI-Public: (01)00827002130913(17)200307(10)7730302
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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-5.0-38-70-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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: 71 YR