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

Catalog Number	A14BX040150170
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to treat patient using a rapidcross balloon at the distal superficial femoral artery.Lesion type was fibrous with little tortuosity and moderate calcification.Artery diameter was 4 mm and lesion length was 150 mm.A 6f sheath was used.An inflation device was used with diluted contrast for inflation.It is reported that balloon burst during first inflation under nominal pressure.No issues were noted prior to use.No resistance noted when advancing the device.A second balloon was used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Evaluation summary: the rapidcross pta rapid exchange balloon dilatation catheter was received for evaluation.No device, ancillary devices, or cine images were received for evaluation.Sanguine residue was noted within the balloon chamber confirming communication between the inflation lumen and sanguine environment had occurred.The balloon chamber of the rapidcross dilatation catheter was placed within a pan of water.A 10 cc water filled syringe was attached to the proximal hub luer lock.The balloon chamber was inflated and a pinhole leak was noted at the distal end of the balloon chamber.

• Brand Name: RAPIDCROSS
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6255829
• Report Number: 2183870-2017-00029
• Device Sequence Number: 1025954
• Product Code: LIT
• UDI-Device Identifier: 00821684067949
• UDI-Public: 00821684067949
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2017

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?: 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: 01/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 03/09/2017; 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1