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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
Upon retracting the sheath during a left leg angioplasty procedure on the male patient, the hub broke.The sheath was able to be removed by hand.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, manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported one (1) used/damaged ksaw-5.0-18/38-90-rb-shtl-hc was returned for investigation with the hub separated from the sheath.The device was returned with a check-flo hemostasis assembly, rather than the tuohy-borst side-arm.The flare had a ruffled appearance and was found to be stretched, resulting in the flare having an oval shape.There is no evidence to suggest the product was not made to specifications.Instructions are in place to verify that the device is manufactured to specification.The process of attaching threaded proximal end fittings to flexor sheaths is validated the process validation shows that the device meets tensile requirements per iso 11070:2014.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, examination of the returned device and the results of our investigation, it is feasible to suggest that during the removal process, the device met force beyond its intended design.We will continue to monitor for similar complaints.Per the health risk assessment no further action is required.
Event or Problem Description
Upon retracting the sheath during a left leg angioplasty procedure on the male patient, the hub broke.The sheath was able to be removed by hand.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.

• 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: 5728578
• Report Number: 1820334-2016-00445
• Device Sequence Number: 510952
• Product Code: DYB
• UDI-Device Identifier: 00827002300095
• UDI-Public: (01)00827002300095(17)190211(10)6729269
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2016

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-5.0-18/38-90-RB-SHTL-HC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2016
• Device Age: 3 YR
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2016
• Supplement Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1