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

Catalog Number	PCU060250130
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a pacific xtreme pta balloon catheter to carry out a procedure on the superficial femoral artery (sfa).The left mid, fibrous lesion was moderately calcified and minimally tortuous.There was 100% lesion stenosis (chronic total occlusion).The lesion length was 300 mm, where the artery was 6 mm in diameter.There was "serious in stent restenosis" related to the anatomy.The sheath was 6f.There was no embolic protection device used.The balloon was inflated with a non-medtronic inflation device.The ifu was followed during preparation and procedure.It was reported that the physician passed the balloon through a previously-deployed stent and encountered no resistance.Upon the second inflation, the balloon ruptured at nominal pressure, 6 atm.It was a circumferential / radial balloon burst.All balloon fragments were retrieved.The procedure was completed with a second pta balloon of the same size and lot.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: the balloon did not fragment and it was removed from the patient in one piece.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the pacific xtreme pta balloon catheter was received for evaluation.Two kinks were noted in the catheter.The kinks were located at the distal tip of the y-manifold strain relief and approximately 29.5cm from the distal tip of the y-manifold strain relief.The kinks most likely happened post-procedure when the catheter was not supported by a guidewire and given how the device was packaged for return.Sanguine residue was noted within the inflation lumen of the catheter and within the balloon chamber.A 10cc water filled syringe was attached to the proximal hub luer lock of the y-manifold.The syringe was pressurized but fluid would not flow the guidewire lumen; most likely due to the kinks.A 10cc water filled syringe was attached to the inflation lumen luer lock on the y-manifold and pressurized; the balloon chamber was able to be inflated.A 20cc water filled syringe with manifold was attached to the inflation lumen luer lock on the y-manifold and the balloon chamber was able to be inflated to nominal pressure of 6 atm.When an attempt to inflate to rated burst pressure was made a leak was noted when fluid flowed out of the guidewire lumen.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC XTREME
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9182223
• Report Number: 9612164-2019-04297
• Device Sequence Number: 3642691
• Product Code: LIT
• UDI-Device Identifier: 08033477075877
• UDI-Public: 08033477075877
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103464
• 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): 11/14/2019

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: 06/11/2022
• Device Catalogue Number: PCU060250130
• Device Lot Number: 217876555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/10/2019; 11/13/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/16/2019; 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 104