MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME OTW; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number SBI050120130

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the device was returned for evaluation.A visual and tactile inspection was carried out on the device with the following results: the balloon was detached and the guidewire lumen underneath the balloon was stretched.No further test could be performed based on the device conditions.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician intended to use an admiral xtreme for treatment of a severely calcified/plaque/fibrous lesion in the patients mid superficial femoral artery(sfa)/popliteal artery(fa).The vessel was reported to be moderately tortuous.The lesion exhibited 80% stenosis.The device was prepped without any issues.No embolic protection was used.The device was passed through a previously deployed stent without any resistance encountered.The balloon was inflated using an inflation device.It was reported that the balloon burst at a pressure of 8bar.It is unknown how many previous inflations were applied to the balloon.Following this, removal difficulties were experienced.No excessive force was used.The endoluminal angiography showed that there were two fragments of balloon in the blood vessel.A capture device was used to remove the material and complete the procedure.No patient injury was reported.

• Brand Name: ADMIRAL XTREME OTW
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7536180
• MDR Text Key: 108977120
• Report Number: 9612164-2018-01196
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062809
• 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
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Catalogue Number: SBI050120130
• Device Lot Number: 214054593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• 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: 76 YR