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

Catalog Number	A14BX025150170
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician attempted to use a rapid cross pta balloon dilatation catheter with a 45cm 6fr non-medtronic sheath and a.014 non-medtronic guidewire during treatment of a fibrous lesion in patients right distal anterior tibial artery (ata).There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.No issues were noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Embolic protection was not used. the vessel was pre-dilated with the rapidcross pta balloon.The vessel was not post-dilated.A medtronic inflation device was used for balloon inflation.50/50 contrast inflation fluid was used.The balloon was not passed through a previously deployed stent.No resistance was noted during advancement of the device.Deflation difficulties were reported.No issues were noted during inflation.Balloon was taken to nominal inflation pressure but would not deflate.There was no damage noted to the balloon catheter.The physician cut the hub off the catheter to allow for balloon deflation.The balloon was eventually fully deflated for removal.The balloon was removed intact.The device was safely removed from the patient.A replacement rapidcross pta balloon was used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis the device was returned with the balloon in a post-inflated state the shaft is cut at the strain relief, and there is a kink on the shaft approximately 40mm from the rx joint, medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: RAPIDCROSS
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19309539
• Report Number: 2183870-2024-00159
• Device Sequence Number: 11532228
• Product Code: LIT
• UDI-Device Identifier: 00763000110857
• UDI-Public: 00763000110857
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2024

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: 07/02/2026
• Device Catalogue Number: A14BX025150170
• Device Lot Number: B588885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Male