MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number PTA3-14-150-2-12

Device Problems Stretched (1601); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2015

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

The complainant reported a cross-over pta (percutaneous transluminal angioplasty) in the crural vessels.Another manufacturer's wire guide was stuck inside the advance micro 14 ultra low-profile pta balloon catheter during recanalization of the crural vessels.It was further noted that the wire guide remained inside the balloon catheter, and a portion of the catheter felt stretched.There were no reported serious injuries to the patient as a result of the product problem.

• Brand Name: ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7591460
• MDR Text Key: 111446194
• Report Number: 1820334-2018-01792
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002266411
• UDI-Public: (01)10827002266411(17)171118(10)5452990
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTA3-14-150-2-12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1