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

Model Number	A35HPV06040080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
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 was attempting to use a fortrex pta balloon along with non-medtronic 7fr sheath and 0.035" guide wire during procedure to treat a none calcified fibrous lesion in the left proximal radio cepahlic artery with 75% stenosis.The vessel diameter and lesion length are 6mm and 40mm respectively.A medtronic inflation device was used to inflate the balloon.There was no damage to device packaging.There was no issue noted while removing device from hoop/tray.The device was prepped per ifu with no issues identified.During second inflation a longitudinal burst occurred at 22atm all balloon fragments were retrieved.The device did not pass through a previously implanted stent.There was no resistance while advancing device.Another medtronic balloon same size was used to complete the procedure.There was no patient injury reported.
Additional Manufacturer Narrative
Product analysis: the fortrex otw pta balloon catheter was returned within a yellow, plastic biohazard bag.Inside the bag, the device was contained within the shelf-box indicated lot number a965621, consistent with the reported lot number.Within the shelf-box the device was contained within the opened sterile label pouch.No ancillary devices or images were received with the device.The device was removed from the shelf-box.Inspection of the distal tip revealed a red blood-like substance, consistent with dried blood.A longitudinal tear was observed along the length of the balloon.The tear was approximately 3.6cm in length.Microscopic inspection revealed the edges of the longitudinal tear.Also, the distal and proximal balloon bonds remained intact and both marker bands were identified.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.
Additional Manufacturer Narrative
Additional information: all balloon fragments were retrieved within the sheath.The device was safely removed from the patient.There was no vessel damage noted.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: 10218812
• Report Number: 2183870-2020-00201
• Device Sequence Number: 2095142
• Product Code: LIT
• UDI-Device Identifier: 00763000105983
• UDI-Public: 00763000105983
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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,Followup
• Report Date (Section B): 09/03/2020

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: 01/24/2023
• Device Model Number: A35HPV06040080
• Device Catalogue Number: A35HPV06040080
• Device Lot Number: A965621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Received by Manufacturer: 06/27/2020
• Supplement Date Received by Manufacturer: 07/09/2020; 09/02/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/14/2020; 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 85