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

Catalog Number AMD030120152

Device Problems Deflation Problem (1149); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician intended to use an amphirion deep balloon to treat a chronic total occlusion (cto) with some calcification in the proximal left tivial/popliteal trunk and anterior tibal artery.A 0.014 guidewire was used for the procedure.There was no damage to the device packaging or to the device when removing it from the hoop/tray.The device was prepped per ifu with no issues.No resistance was encountered during advancement and no excessive was used.A medtronic inflation device was used with saline for inflation of the balloon.It was reported that the balloon would not deflate at the lesion site.The deflation issues were noted during subsequent inflation.The device moved in the lesion while it was inflated.Removal difficulties were encountered and there was difficulty removing the balloon following inflation.The device did not pass through a previously deployed stent.No patient injury was reported.

Manufacturer Narrative

Additional information: the balloon would not deflate, the balloon was perforated percutaneously with needle to deflate.Recanalization of the entire tibial trunk was achieved.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Two photographs of the device on top of the original box and a procedure summary report were received for analysis.Due to the quality and clarity of the photograph provided of the device manifold it is not possible to confirm the lot number on the device.The lot number on the original shelf carton is consistent the information provided in the complaint form.Due to the quality and clarity of the photographic images provided the distal tip and distal marker band were positively identified.This indicates that all components were accounted for.In the images provided the 3mm diameter balloon chamber is in a post-inflation profile, (e.G.Not tightly wrapped or winged).A series of kinks were noted in the catheter.It is not known when the kinks occurred, (during the procedure or post procedure).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; avenida paseo del cucapah #105; parque industrial el lago; tijuana b.c.,mx ; MX
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana b.c.,mx ; MX
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8342596
• MDR Text Key: 136261233
• Report Number: 9612164-2019-00526
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K052791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2021
• Device Catalogue Number: AMD030120152
• Device Lot Number: 215791898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2019
• Date Device Manufactured: 07/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR