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

Catalog Number	A14BX030210170
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the rapidcross was returned for evaluation.No ancillary devices were included the returned contents.A visual inspection of the device was completed and it was noted that the rapidcross was returned in a post-inflated stated with red tinted fluid (likely blood) observed within the balloon segment.The working length of the returned rapidcross was 170cm, which aligns with the product labeling.All four marker bands were noted within the balloon segment.The blue inner catheter showed serpentine type bending within the balloon segment.No tears or holes were observed upon the initial inspection.The rapidcross was connected to an inflation device filled with water.Pressure was administered and a stream of water was observed coming from the proximal end of the balloon.A pinhole was identified at approximately 18cm proximal to the distal tip of the catheter.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a rapidcross for treatment of the patients mid anterior tibial artery (ata).Ifu was followed and the device was prepped without issue.It is reported a balloon leak/burst occurred at an inflation pressure of 8atm, on the first inflation with a non-mdt inflation device.The technician observed blood inside the balloon.It could not be determined if this was due to a micro tear on the balloon or if blood entered the balloon after pulling negative pressure after the first inflation.No damage was noted to the balloon upon removal.A new balloon was used to complete the procedure.No patient injury 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: 7849896
• Report Number: 2183870-2018-00434
• Device Sequence Number: 19166905
• Product Code: LIT
• UDI-Device Identifier: 00821684067642
• UDI-Public: 00821684067642
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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: 06/04/2021
• Device Catalogue Number: A14BX030210170
• Device Lot Number: A655823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR