MAUDE Adverse Event Report: COVIDIEN RAPIDCROSS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number A14BX020150170

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2022

Event Type  malfunction  

Event Description

Physician was attempting to use a rapidcross pta balloon during procedure to treat a moderately calcified plaque lesion in the mid a nterior tibial artery (ata). The vessel was little tortuous. No embolic protection was used. A non-medtronic inflation device was used for balloon inflation. There was no damage noted to packaging. There was no issue noted when removing device from hoop/tray. The device was prepped per ifu with no issues identified. Balloon deflation difficulties was reported with device not able to deflate at lesion site. The deflation issue was noted following the first inflation. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. It was reported that physician was unable to deflate balloon even pulling negative with inflation device and syringe. Physician was forced to pull out the balloon while it was still inflated at 6atm. No vessel damage occurred. There was no patient symptoms or complications associated with this event. There was no patient injury reported.

Manufacturer Narrative

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

• Brand Name: RAPIDCROSS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14111361
• MDR Text Key: 289271841
• Report Number: 2183870-2022-00138
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: A14BX020150170
• Device Catalogue Number: A14BX020150170
• Device Lot Number: B320808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No