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

Catalog Number	A14BX035060170
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/29/2019
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
During use of a rapidcross balloon it is reported that the balloon came off the wire during the procedure.It is reported the remnants of the balloon were removed from the patient.The patient was brought back later for stenting.No further patient injury reported for this event.

• Brand Name: RAPIDCROSS
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8635444
• Report Number: 2183870-2019-00303
• Device Sequence Number: 11217921
• Product Code: LIT
• UDI-Device Identifier: 00821684067703
• UDI-Public: 00821684067703
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2019
• Device Catalogue Number: A14BX035060170
• Device Lot Number: A360893
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/23/2019
• 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: Required Intervention
• Patient Weight: 101