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

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Additional information: the previously deployed stent was not dislodged or damaged.The physician attempted to use a snare to retrieve the balloon but was unsuccessful.The entire balloon was jailed in the distal sfa by deploying an everflex stent.No further treatment has been scheduled and the patient is doing fine.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Physician used a rapidcross balloon during treatment of a lesion in the patient¿s mid popliteal artery.Ifu was followed.No damage noted to packaging nor issues noted when removing the device from the hoop.Ifu was followed.The device was prepped without issue.An inflation device was used for balloon inflation.The rapidcross was passed through a previously deployed stent.Resistance was encountered when advancing the device.It is reported excessive force was used during withdrawal of the device as the balloon became caught on a previously deployed stent.This resulted in the balloon detaching from the catheter.The remnants of the balloon were then jailed by deploying a stent to cover.

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; 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: 9260821
• MDR Text Key: 175499156
• Report Number: 2183870-2019-00529
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention