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

Catalog Number	A14BX020080170
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photograph analysis summary: the rapidcross pta rapid exchange balloon dilatation catheter was not received for evaluation.A single photographic image of the device was provided.The photographic image is of a coiled up rapidcross dilatation catheter being held in a gloved hand.The image includes the distal tip and distal portion of the balloon chamber.The balloon chamber is in a pre-inflation profile.The proximal wire port can be identified and no cracks, separation, or damage to the guidewire lumen can be seen.Two kinks were observed just proximal to the proximal guidewire port.The kinks are severe enough to have caused kinking of the rapidcross push wire within the inflation lumen.Due to the severity of either of the kinks the inflation lumen pathway may have been compromised.Other than the kinks in the catheter there are no signs of catheter fracture.The kinks would have compromised the rapidcross advancement through a support sheath.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a rapidcross device to treat a non-tortuous lesion with little calcification in the mid right superficial femoral artery.The device was prepped as per ifu with no issues identified.No embolic protection was used.The device did not pass through a previously deployed stent.It was reported resistance was encountered advancing the device to the lesion.The device was reported to have fractured.The catheter was removed over the wire, all components of the device were removed from the patient without a need for intervention.The procedure was completed using a nanocross device, with no complications reported.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: 7540037
• Report Number: 2183870-2018-00286
• Device Sequence Number: 14081434
• Product Code: LIT
• UDI-Device Identifier: 00821684067246
• UDI-Public: 00821684067246
• 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): 05/24/2018

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: 08/31/2020
• Device Catalogue Number: A14BX020080170
• Device Lot Number: A518075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1