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

Catalog Number A14BX025210170

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

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 for evaluation.The catheter was received in a post-inflation profile i.E.Not tightly wrapped or winged.The balloon chamber material exhibited wrinkling.The inner guidewire lumen within the balloon chamber exhibited accordion folding and twisting.A 0.014¿ compatible guidewire was loaded through the distal tip of the rapidcross dilatation catheter.Slight resistance was noted during loading of the guidewire.It was noted that the guidewire exited the inner guidewire lumen and entered the inflation lumen pathway.The inner guidewire lumen was twisted and accordion folded proximal to the point it exited the inner guidewire lumen.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician intended to use a rapidcross balloon with a non-medtronic guidewire during treatment of the patient¿s popliteal artery.The physician inserted the guidewire and delivered it to the distal of the target lesion.Delivery of the rapidcross device was then started.It was reported that the guidewire was found exposed from the balloon, not from the rx port.Resistance was experienced.No patient injury was reported.

• Brand Name: RAPIDCROSS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7867796
• MDR Text Key: 119931152
• Report Number: 2183870-2018-00438
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• Device Catalogue Number: A14BX025210170
• Device Lot Number: A570952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1