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

Catalog Number	A14BX030080170
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to use a rapidcross pta balloon with a non-medtronic 7fr x45cm sheath to treat a fibrous lesion with 50% stenosis in the moderately tortuous mid tibial/popliteal trunk.The device was prepped as per the ifu with no issues identified.Negative prep was performed.No resistance was experienced when advancing with the device.The device was not passed through a previously deployed stent.It was reported that a pinhole balloon burst occurred during the inflation of the device with a non-mdt device and isovue contrast and heparinised saline to 2atm.The procedure was competed using another 3x80 nanocross balloon.No patient injury was reported.
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: 8235218
• Report Number: 2183870-2019-00016
• Device Sequence Number: 18886032
• Product Code: LIT
• UDI-Device Identifier: 00821684067567
• UDI-Public: 00821684067567
• 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,Followup
• Report Date (Section B): 03/28/2019

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: 09/13/2021
• Device Catalogue Number: A14BX030080170
• Device Lot Number: A707391
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1