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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO AMPHIRION DEEP OTW; CATHETER, PERCUTANEOUS Back to Search Results
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.
 
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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 Key10442238
MDR Text Key204016127
Report Number9612164-2020-03102
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K052791
Number of Events Reported1
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 Date03/19/2023
Device Catalogue NumberAMD225210152
Device Lot Number219735582
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Initial Date Manufacturer Received 08/20/2020
Initial Date FDA Received08/24/2020
Supplement Dates Manufacturer Received08/24/2020
10/08/2020
Supplement Dates FDA Received09/01/2020
10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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