MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	A35HPV04020040
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2020
Type of Reportable Event	Malfunction
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 fortrex high pressure balloon during treatment of an arteriovenous fistula (avf).Ifu was followed.No damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.The device was not passed through a previously deployed stent and no resistance was encountered during advancement.It is reported that multiple inflations to 18-20atm were applied to the device using a non-medtronic inflation device.On the second or third inflation, the physician noted that pressure could not be maintained but could identify any leaks on the device.The physician suspects a tear in the device but could not identify where the leak was coming from.The physician could not see any contrast leaking from the hub.The device was safely removed from the patient without any fragments being left in the patient as the balloon was intact.A pacific plus pta balloon and inpact drug coated balloon were then used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
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: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10016790
• Report Number: 2183870-2020-00137
• Device Sequence Number: 16686350
• Product Code: LIT
• UDI-Device Identifier: 00763000105709
• UDI-Public: 00763000105709
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K142654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2022
• Device Model Number: A35HPV04020040
• Device Catalogue Number: A35HPV04020040
• Device Lot Number: A827521
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1