MAUDE Adverse Event Report: COVIDIEN RAPIDCROSS; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	A14BX035040170
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapidcross pta rapid exchange balloon dilatation catheter was not received for evaluation.No ancillary devices or cine images from the procedure were received.A single photographic image was received.The photographic image is of a rapidcross dilatation catheter with a portion covered by surgical gauze.A portion of the catheter is not captured in the image of the coiled dilatation catheter.Due to the quality and clarity of the image it is not possible to identify if balloon chamber material is present.Due to the quality and clarity of the image it is not possible to determine the type of balloon burst.The photograph of the rapidcross dilatation catheter appear to have sanguine material within the inflation lumen: indicating communication between the inflation lumen and the sanguine environment.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a rapid cross to treat a moderately calcified lesion in the tibial/popliteal trunk.The ifu was followed and the device was prepped without issue.It was reported that a balloon burst occurred during inflation at a unknown pressure.The procedure was completed using a replacement balloon.No patient injury was reported.

• Brand Name: RAPIDCROSS
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7952277
• Report Number: 2183870-2018-00462
• Device Sequence Number: 13811818
• Product Code: LIT
• UDI-Device Identifier: 00821684067680
• UDI-Public: 00821684067680
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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 Expiration Date: 11/06/2020
• Device Catalogue Number: A14BX035040170
• Device Lot Number: A552524
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1