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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during the exchange of the sheath for a shorter one the hub came off causing unnecessary bleeding during a peripheral intervention procedure.The sheath was reportedly placed in the groin, a stiff angle glide wire was being used through the sheath and the separation occurred during removal.Reportedly "the facility exchanged the sheath to a new one to complete the procedure.The blood loss was minimal and brief bleeding.There was no adverse consequence to this event." a section of the device did not remain inside the patient¿s body.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
A review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, trends, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, 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.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 (b)(4).Although the event is consistent with a device that has been exposed to forces beyond its intended design, without evaluation of the returned product we cannot determine with certainty what led to the alleged failure.Therefore, a conclusive root cause is unable to be determined.Per the health risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6149048
• Report Number: 1820334-2016-01492
• Device Sequence Number: 52343
• Product Code: DYB
• UDI-Device Identifier: 00827002299863
• UDI-Public: (01)00827002299863(17)190908(10)7256618
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL2-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 06/06/2017
• 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: Other
• Patient Age: 48 YR
• Patient Weight: 111