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

Catalog Number	AMP020150152
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician was treating a lesion in the tibial/popliteal trunk using amphirion deep dilatation balloon catheter.It was reported that the physician experienced removal difficulties following balloon inflation.The catheter/delivery system deformed.The catheter was removed with sheath.The balloon went down to lesion (anterior tibial) without incident.Inflated and came down without incident.The problem occurred while removing the balloon.Antegrade stick with a 5fr raabe cook sheath.The balloon got stuck in the valve of the sheath.Balloon catheter broke while pulling it out.Physician grabbed the broken portion of the balloon catheter and pulled it all out with the wire.It was reported that the patient was obese and the sheath could have kinked causing the balloon difficulties in being removed.By the time the balloon broke and the physician grabbing the other portion of the catheter and pulling it out, happened so quick it was difficult to tell what happened.There was no injury to patient.
Additional Manufacturer Narrative
(b)(4).Traces of blood detected on the shaft and balloon.The device was returned broken on the distal portion.The shaft was broken on the proximal portion of the balloon and the guide wire tube was stretched.It was not possible insert the guide wire in the distal portion due to damage reported.No further analysis could be performed.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
If information is provided in the future, a supplemental report will be issued.

• Brand Name: AMPHIRION DEEP US
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 6525978
• Report Number: 9612164-2017-00525
• Device Sequence Number: 13770201
• Product Code: DQY
• UDI-Device Identifier: 08033477045849
• UDI-Public: 08033477045849
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2017

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: 07/31/2019
• Device Catalogue Number: AMP020150152
• Device Lot Number: 211885738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: Not provided; 05/23/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 06/22/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR