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

Catalog Number A14BX030210170

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

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 0.014" rx pta balloon catheter as part of the procedure on the anterior tibial artery.The mid lesion was moderately calcified.The sheath was a non-medtronic 5f device.There was no embolic protection used.The balloon was inflated with a non-medtronic inflation device.The ifu was followed during the preparation and procedure.It was reported that the physician had finished the procedure and the balloon was stuck in the artery.There was heavy resistance felt when trying to retrieve the device.Excessive force was used, causing the balloon to separate from the catheter, leaving fragments in the artery.The procedure was complete by the physician using a snare to retrieve the fragments.No patient injury was reported.

Manufacturer Narrative

Additional information: the lesion exhibited 70% stenosis.The balloon was inflated to 8atm.The balloon was fully deflated when the issue occurred.No vessel damage occurred as a result of this issue.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the rapidcross dilation catheter was received for analysis.No ancillary device nor procedural cines were received for evaluation.The rapidcross catheter was received in three segments.A proximal segment including the manifold loaded in transportation hoop, and two loose segments.An inventory of the rapidcross catheter concluded that all components were accounted for.The proximal segment terminated at the proximal wire port and exhibited tensile stretching.The proximal guidewire segment exhibited tensile stretching at the proximal wire port.The proximal wire port exhibits ¿pitcher mouth¿ deformation most likely caused due to wire prolapse.The proximal marker band was accounted for.The proximal balloon terminated at a radial tear.The distal segment included the inner guidewire lumen, middle marker bands, distal marker band, distal tip and balloon chamber material.The proximal end of the balloon chamber material exhibited a radial tear and bunching up of the balloon chamber material.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: 9184445
• MDR Text Key: 163159708
• Report Number: 2183870-2019-00497
• 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
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: A14BX030210170
• Device Lot Number: A875732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 10/14/2019; 01/09/2020
• Supplement Dates FDA Received: 10/15/2019; 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• 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