MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number PCU060300130

Device Problems Deflation Problem (1149); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Fistula (1862); Vascular Dissection (3160)

Event Date 11/09/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a pacific xtreme pta balloon catheter along with non-medtronic 7fr sheath and 0. 014" 300cm guidewire during procedure to treat a little calcified plaque lesion in the mid to distal popliteal artery. The vessel diameter and lesion length are 6mm and 100mm respectively. A medtronic inflation device was used for balloon inflation. Inflation fluid used was a contrast 30% and saline70% solution. There was no damage noted to packaging. There was no issue noted when removing device from hoop/tray. The device was prepped per ifu with no issues identified. Balloon deflation difficulties was reported. The deflation issue was noted during subsequent inflation. During withdrawal back into sheath, the catheter broke and the detached piece was removed with a snare. The device passed through a previously deployed stent. No resistance was encountered when advancing the device. More balloons and stents were needed to complete the procedure as a result of the balloon issue. It was reported that the balloon was used to pre dilate the lesion before stenting with a 6mm non-medtronic stent, then also used to post dilate the stent. After the post dilation inflation, the balloon would not deflate. The physician debated puncturing the balloon with a needle percutaneously in order to deflate the balloon, but before that was done, it was noticed that with steady gentle traction against the sheath tip, the balloon was slowing deflating. It was during this process that the catheter shaft broke. Physician snared the retained piece of the balloon and catheter. After snaring, it was noticed that the distal end of the stent was now deformed and a dissection had extended through the popliteal to the tibial/popliteal trunk (tpt) arteries. Multiple balloon inflations and additional stenting was performed to help correct this and improve flow. The patient also developed an av fistula in the tpt. This was relatively slow flow initially but increased quite dramatically over the following 24 hours and ultimately had to be repaired with a covered stent the day after index procedure. Physician reported that the issue with this balloon caused a cascade of additional work that needed to be performed on the patient. A dissection of the popliteal and tpt arteries that require further intervention and stenting. Patient injury of vessel damage and dissection occurred.

• Brand Name: PACIFIC XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 10866197
• MDR Text Key: 217090934
• Report Number: 9612164-2020-04470
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PCU060300130
• Device Catalogue Number: PCU060300130
• Device Lot Number: 220526894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/19/2020 Patient Sequence Number: 1