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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The age of the patient at the time of event is not clear.Date of birth was reported as 1947.The patient is 69 or 70 years of age.(b)(4).The reported device, flexor raabe guiding sheath, was returned for evaluation.Visual inspection of the device noted a hub separated and sheath showed no signs of separation.The flare was checked with an appropriate flare gauge and the inner diameter of the connector cap is within specification.No events related to the reported issue were found during a review of related manufacturing or quality records.Review of the associated device history record did not identify non-conformances that may be related to this reported incident.Based on exam of the returned device, a conclusive cannot be determined.
Event or Problem Description
As reported to customer relations: during an iliac/sfa procedure, the hub of the flexor raabe guiding sheath came apart as the sheath was over the wire.Another manufacturer's sheath was used to complete the procedure.Per additional information received on (b)(6) 2017, while retracting the flexor raabe guiding sheath, the hub came apart from sheath itself.It was stated the patient's iliac was tortuous.The sheath and stent were both removed manually over the wire.Another manufacturer's sheath was used to complete the procedure.No fragments remained inside the patient, the patient was unharmed.No additional details have been received.
Additional Manufacturer Narrative
(b)(4).

• 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: 6377869
• Report Number: 1820334-2017-00352
• Device Sequence Number: 918460
• Product Code: DYB
• UDI-Device Identifier: 00827002116337
• UDI-Public: (01)00827002116337(17)180119(10)5588422
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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: KCFW-7.0-38-55-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR