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

Model Number A14BX025210170

Device Problems Fracture (1260); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a rapidcross pta balloon with a non-medtronic 6fr sheath and a 0.014 non-medtronic guide catheter during treatment of a calcified lesion in the patient¿s mid anterior tibial artery.Lesion exhibited 80% stenosis.Moderate vessel calcification and tortuosity are reported.No issues noted when removing the device from packaging.Ifu was followed.An inflation device was used for balloon inflation.It is reported that a break/fracture occurred on the distal half of the balloon catheter.It is unclear when the fracture occurred.There were no detached components.The device was removed from the patient without issue over the wire.A new rapidcross balloon was used to complete the procedure.No patient injury reported.

Manufacturer Narrative

Additional information: the fracture occurred during balloon advancement through the guide catheter medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the rapidcross rapid exchange balloon dilatation catheter was returned to the medtronic analysis lab for analysis.The device was returned in its post inflation profile.Crystalline material was observed within the balloon chamber.No abnormalities were noted on the distal tip.A 0.014" guidewire from the lab was front-loaded the catheter.The guidewire exited outside of the rapid exchange port.An inflation device filled with water was connected to the manifold.At approximately 2atm water was observed exiting out of the catheter lumen.The pin hole leak was located approximated 16cm proximal from the distal tip.Visual inspection under magnification reveal a pin hole leak.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 9325874
• MDR Text Key: 179527281
• Report Number: 2183870-2019-00541
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684067482
• UDI-Public: 00821684067482
• Combination Product (y/n): N
• PMA/PMN Number: K130911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2021
• Device Model Number: A14BX025210170
• Device Catalogue Number: A14BX025210170
• Device Lot Number: A618367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1