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

Catalog Number	PCP070060130
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
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 hawkone h1-m device with a non-medtronic 7fr sheath and 0.014 non-medtronic device during treatment of an 80mm 90% stenotic fibrous, calcified lesion in the patient¿s right proximal superficial femoral artery (sfa) of diameter 7mm.Severe tortuosity and moderate calcification were reported.The ifu was followed and the device was prepped without issue.The vessel was pre-dilated.The device did not pass through a previously deployed stent, no resistance was encountered when advancing the device and no excessive force was used.However, the hawkone was unable to reach the lesion.A non-medtronic atherectomy device was used to treat the lesion.This was followed by a 7x60 pacific plus device.The device was inflated to 5atm using a non-medtronic device but the balloon burst.All fragments of the balloon were retrieved.A non-medtronic balloon was used to treat the common femoral.No patient injury was reported.
Additional Manufacturer Narrative
Image review: four photographic images of cine images were received for evaluation.The images are of the patients right proximal superficial femoral artery.The vessel exhibits tortuosity and calcification.In three of the four images a hawkone directional atherectomy device can be identified.In the second image only a support sheath, guidewire, and a radiopaque marker on the guidewire could be identified.A pta could not be identified in any of the four images.Technical analysis of the images is inconclusive for a pacific plus pta balloon bursting at 5atm when inflated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the balloon was safely removed from the patient.No intervention required.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC PLUS US
• 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: 8798169
• Report Number: 9612164-2019-02911
• Device Sequence Number: 14271053
• Product Code: LIT
• UDI-Device Identifier: 08033477054391
• UDI-Public: 08033477054391
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123358
• 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): 09/06/2019

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: 12/13/2021
• Device Catalogue Number: PCP070060130
• Device Lot Number: 216784219
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/24/2019; 09/05/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 07/25/2019; 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 127