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

Catalog Number	A14BX040150170
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the rapidcross pta rapid exchange balloon dilatation catheter was received for evaluation.No ancillary devices or cine images from the procedure were received.Not all components of the rapidcross dilatation catheter were received.Upon visual examination, the majority of the balloon chamber material, approximately 160mm of inner guidewire lumen including the distal tip, and four radiopaque markers were not returned for evaluation.The separation of the balloon chamber material occurred in the region of the balloon chamber¿s proximal cone.The guidewire lumen proximal port was examined: no signs of guidewire prolapse are present.The proximal balloon bond is present.The proximal balloon separation face exhibits circumferential radial tearing.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a rapidcross with a 6fr 90cm destination sheath and.014 300cm guidewire for treatment of a moderately calcified lesion with little degree of tortuosity in the distal superficial femoral artery.Lesion exhibited 40% stenosis.Patient had a bi aortic iliac bypass graft.The device was prepped as per ifu without any issues identified.The balloon burst following second inflation at an inflation pressure of 10 atm¿s.The physician attempted to snare it (using a gooseneck snare) but the device wasn¿t long enough because of access in the right brachial artery.When the physician tried to remove the burst balloon through the sheath, it got caught on the wire and the sheath resulting in the distal tip breaking off.Physician also attempted to retrieve it using the basket on a 7mm spider.Surgery was required to retrieve the tip of the balloon which remained in the graft which was completed the next day.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RAPIDCROSS
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6659391
• Report Number: 2183870-2017-00269
• Device Sequence Number: 211137
• Product Code: LIT
• UDI-Device Identifier: 00821684067949
• UDI-Public: 00821684067949
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: A14BX040150170
• Device Lot Number: A352452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 09/07/2017
• 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