MAUDE Adverse Event Report: MEDTRONIC MEXICO AMPHIRION DEEP OTW; CATHETER, PERCUTANEOUS

Catalog Number AMD225210152

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used an amphirion deep pta balloon during treatment of the patients anterior tibial artery.It is reported that when inflated the balloon burst.A second amphirion deep balloon of the same model was used to complete the procedure.No injury reported.

Manufacturer Narrative

Additional information: the balloon burst at 7 atm, nominal pressure.No prior inflations were applied prior to the balloon burst.There were no difficulties when removing the device from the patient.The balloon did not fragment.All components of the device were removed from the patient.There was no vessel damage noted.No further patient injury reported.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 amphirion deep pta balloon catheter was received into medtronic investigation lab for evaluation.The device was received within a sealed plastic biohazard pouch, within its opened labeled shelf carton, within its opened labeled pouch, and loosely coiled within a knotted shut plastic pouch.The lot number data printed on the y-manifold is consistent with the pouch label, shelf carton label, and reported event.No ancillary devices nor procedural images were received for analysis.The amphirion deep balloon catheter was received in a post-inflation profile, (e.G.Not tightly wrapped or winged).The catheter had several kinks along its length.The kinks most likely happened post procedure given how the device was packaged for return.The proximal end of the balloon chamber material exhibited folding witness marks as if it had been pulled proximally against resistance.A 10cc water filled syringe was attached to the proximal hub luer lock.The syringe was pressurized but would not flush the guidewire lumen.The guidewire lumen is most lik ely occluded with biologics and contrast residue from the procedure.Since the guidewire lumen could not be flushed loading of a guidewire was not attempted.A 10cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold and a vacuum could be pulled.The syringe was pressurized lightly, and the balloon chamber could be inflated.A 20cc water filled syringe with manometer was attached to the inflation lumen luer lock of the y-manifold and the balloon chamber was inflated to nominal pressure of 7atm, no leaks nor tears in the balloon catheter were noted.A vacuum was pulled, and the balloon chamber was fully deflated.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.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: AMPHIRION DEEP OTW
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10442238
• MDR Text Key: 204016127
• Report Number: 9612164-2020-03102
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K052791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Catalogue Number: AMD225210152
• Device Lot Number: 219735582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 08/24/2020; 10/08/2020
• Supplement Dates FDA Received: 09/01/2020; 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1