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

Catalog Number A14BX025210170

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 03/22/2017

Event Type  Injury  

Event Description

Physician attempted to treat patient at the anterior tibial artery using a rapidcross balloon.It is reported the target lesion had severe tortuosity, severe calcification and 100% stenosis.Stenosis was proximal to the target lesion.Device was prepped as per ifu.It is reported that physician felt resistance when delivering the balloon catheter.For that reason, physician then attempted to remove the catheter.When the physician started pulling the catheter, the distal end of the shaft detached.The detached segment was removed using a snare device.Procedure time is reported to have been extended by over 30 minutes.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RAPIDCROSS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6507911
• MDR Text Key: 73331263
• Report Number: 2183870-2017-00182
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2019
• Device Catalogue Number: A14BX025210170
• Device Lot Number: A267104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Date Device Manufactured: 04/25/2016
• 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
• Patient Outcome(s): Required Intervention