MAUDE Adverse Event Report: COOK INC FLEXOR BALKIN 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During placement of an iliac stent, towards the end of the procedure the physician went to take out the device and the hub came off.The procedure was completed with this device.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
(b)(4).Initial was filed within the 30 day time frame regardless of corrected date.Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.One (1) used kcfw-7.0-35-40-rb-blkn was returned for investigation.The flare appeared to be slightly distorted and white stress marks were found on the interior of the flare.The flare size was tested using an appropriate go no-go flare gauge, and passed, thus confirming the flare size was manufactured to specification.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.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.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Based on the information provided, examination of the returned device and the results of our investigation , it is feasible to suggest the reported failure mode was caused by the device meeting resistance beyond it's intended design.We will continue to monitor for similar complaints.Per the health risk assessment no further action is required.
Event or Problem Description
During placement of an iliac stent, towards the end of the procedure the physician went to take out the device and the hub came off.The procedure was completed with this device.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 BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5664381
• Report Number: 1820334-2016-00367
• Device Sequence Number: 16266065
• Product Code: DYB
• UDI-Device Identifier: 00827002104051
• UDI-Public: (01)00827002104051(17)170201(10)F4803007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2016

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: KCFW-7.0-35-40-RB-BLKN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 11/23/2016
• 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: Other