MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a surgery for abdominal angiogram, atherectomy and balloon angioplasty, the micropuncture transitionless pedal access set, nitinol wire guide, broke off.The surgeon achieved tibial access of the anterior tibial artery.The head of the guide wire, included within the anterior tibial access kit, which also includes the 4 french sheath, sheared off into the tibial artery, which was already occluded.The surgeon was able to retrieve and pull the wire out of the tibial artery, but the wire became lodged in the subcutaneous tissue.The surgeon attempted twice to remove the wire, but deemed that it was unsafe to remove the wire blindly using fluoroscopy and a hemostat.The surgeon decided it was safer to leave the wire in the subcutaneous tissue.The surgeon did not proceed with the anterior tibial artery revascularization.Further information was requested regarding the patient's status, however, no additional information has been received.
Additional Manufacturer Narrative
The information in this report, excluding evaluation, was provided to the manufacturer via (b)(4).Additional information: (b)(6).Investigation - evaluation a review of the complaint history, device history record, documentation, specifications and quality control of the device was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record noted one nonconformance for a broken solder near the tip which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Without visual, dimensional, and/or functional testing of the product, the manufacturer was unable to determine if the reported event was related to a manufacturing issue.Clinical factors that may have contributed to the reported event include the patient's occluded tibial artery.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6413105
• Report Number: 1820334-2017-00513
• Device Sequence Number: 13637532
• Product Code: DYB
• UDI-Device Identifier: 00827002029729
• UDI-Public: (01)00827002029729(17)191209(10)7506862
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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: MPIS-401-PEDAL-NT-U-SST
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 05/10/2017
• 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: 62 YR
• Patient Weight: 86