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

Model Number	PCU060150130
Medical Device Problem Codes	Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image review: three photographic images of cine images were received for evaluation.The images are of the patient¿s distal right superficial femoral artery.A radiopaque ruler is in all three images.In the first image the pta balloon catheter is inflated.A candy wrapper twist/ ¿dog boning¿ is visible in the image at approximately the 24cm mark on the radiopaque ruler.The second image is of the pta balloon catheter inflated but no candy wrapper twist/ ¿dog bone¿ is visible in the image.The third image appears to be a cropped enlargement of the pta balloon catheter inflated with a candy wrapper twist/ ¿dog bone¿ visible in the image at approximately 21cm mark on the radiopaque ruler.Product analysis: two pacific xtreme pta balloon catheters were received loaded within their protective transportation hoops.Neither of the balloons nor the hoops were identified as being the first unit used or second unit used in the procedure.No ancillary devices were received for evaluation.One of the pacific xtreme pta balloon catheters was randomly selected to be the first unit used in the procedure.The balloon catheter was received with the balloon chamber in a post-inflation profile, (e.G.Not tightly wrapped or winged).No obvious balloon chamber material twisting, (candy wrapping or dog boning), witness marks were noted in the visual inspection.A 10cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed; sanguine residue and tinted fluid was observed exiting the distal tip of the balloon catheter.A 0.018¿ compatible guidewire was loaded through the distal tip of the balloon catheter and navigated with ease out the proximal hub luer lock of the y-manifold.The lot number data printed on the y-manifold is consistent with the reported event.A 10cc water filled syringe was used to lightly inflate the balloon chamber.Faint witness marks of a balloon chamber material twist were noted.
Event or Problem Description
Physician intended to use a pacific xtreme pta balloon to post-dilate a non-medtronic stent during treatment of a 300mm cto (chronic total occlusion-100%) in the patient¿s distal right superficial femoral artery (sfa) of diameter 6mm.Moderate vessel tortuosity and calcification are reported.No damage noted to packaging prior to use.No issues noted when removing the device from the packaging.Ifu was followed and negative prep was performed without issue.Pre-dilation was not performed.The device was passed through the deployed stent without encountering resistance post atherectomy.It is reported that during attempted inflation, dog-boning was observed at an inflation pressure of 3atm.The device was replaced with another pacific xtreme device, but the same issue was experienced at an inflation pressure of 6atm.There was no twist or kink noted on the balloons when removed from the patient.Both devices were safely removed from the patient.No vessel damage occurred.A non-medtronic balloon was used to complete the procedure.A non-medtronic stent was placed.No patient injury reported.

• 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: 10086266
• Report Number: 9612164-2020-01974
• Device Sequence Number: 11475745
• Product Code: LIT
• UDI-Device Identifier: 08033477075839
• UDI-Public: 08033477075839
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 05/26/2020

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: 12/09/2022
• Device Model Number: PCU060150130
• Device Catalogue Number: PCU060150130
• Device Lot Number: 219105117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 68