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

Catalog Number	A14BX030040170
Medical Device Problem Codes	Break (1069); Burst Container or Vessel (1074)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a rapidcross balloon with a.014 non-medtronic guidewire during treatment a lesion in the distal anterior tibial artery.Moderate tortuosity and calcification are reported.Ifu was followed.It is reported that the balloon broke, and the patient was transferred for surgery to have the broken piece removed.
Additional Manufacturer Narrative
Product analysis: the rapidcross was returned without any ancillary devices.The rapidcross was returned with dried blood throughout the catheter.The catheter shaft detached at the area of the rx port of the catheter.Approximately 7cm of the tip wire was exposed outside of the catheter shaft outer.The distal portion which included the balloon was not returned.The approximate working length of the returned rapidcross was 139cm.A bend to the catheter shaft was noted at approximately 44cm.The area of the catheter separation was observed under microscope.The surface showed rounded edges and separated at the bond area.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: a 6fr non-medtronic sheath was used.The pta procedure was being carried out through an existing bypass (bypass was cannulated).The balloon did not break as was previously reported.The shaft of the balloon broke approximately 15-20cm from the distal tip.The patient was discharged from hospital.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RAPIDCROSS
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9151159
• Report Number: 2183870-2019-00478
• Device Sequence Number: 2782649
• Product Code: LIT
• UDI-Device Identifier: 00763000110918
• UDI-Public: 00763000110918
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: A14BX030040170
• Device Lot Number: A875729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/08/2019; 01/08/2020; 01/10/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/22/2019; 01/09/2020; 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 73