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

Model Number A14BX040150170

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Device Damaged by Another Device (2915)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a rapidcross pta balloon with a non-medtronic 6fr sheath and 0. 014 non-medtronic wire during treatment of a 150mm cto (chronic total occlusion - 100%) in the patient¿s distal superficial femoral artery (sfa). Severe vessel calcification is reported. Artery diameter reported as 6mm. A non-medtronic (bard) inflation device was used for balloon inflation. There was no damage noted to the product packaging prior to use. No issues were noted when removing the device from the packaging. Ifu was followed and the device was prepped without issue. It is reported once the sfa cto was crossed and confirmed, the 0. 014 non-medtronic wire was placed, and the rapidcross balloon was advanced into the distal sfa at the re-entry area. The balloon was inflated 3 times in the sfa and on the 4th time a longitudinal burst at 14atm is reported. When the physician was removing balloon, resistance was felt coming into the sheath. The physician gently tugged on the catheter, but it would not move. The physician then tugged on the wire and fond the wire was stuck onto the balloon and the sheath. The physician then used a buddy wire and had to remove the whole sheath due to the balloon inside of the sheath being occlusive. The patient¿s sfa was inspected and the physician did not angiographically see any remainder of balloon. A new pta balloon was used to complete the procedure. No patient injury 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 ; EI ; 091708734
• MDR Report Key: 11045308
• MDR Text Key: 222634447
• Report Number: 2183870-2020-00447
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: A14BX040150170
• Device Catalogue Number: A14BX040150170
• Device Lot Number: B057801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage