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

Model Number	PCU060200130
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
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
Physician intended to use a pacific xtreme device during patient treatment.No damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.It is reported during the procedure the balloon twisted midshaft and created a waist.The same issue is reported for a second pacific xtreme device.No patient injury reported.
Additional Manufacturer Narrative
Image review: a single photograph of a cine image was received for analysis.The procedure is happening in the patient¿s right superficial femoral artery.In the image the pacific xtreme pta balloon catheter exhibits a balloon twist.Product analysis: two pacific xtreme devices were returned to medtronic investigation lab for evaluation.The device was returned within a clear biohazard bag.The devices were in their individual shelf boxes.Catheter 1 was examined.The catheter was returned in a post inflation profile.Blood residue was observed within the balloon chamber.A kink/twist was observed on the balloon chamber.The kink/twist is approximately 7.5mm proximal from the distal tip.No abnormality was noted on the distal tip.Blood residue was observed within the catheter hub.Catheter 2 was examined.The catheter was returned in a post inflation profile.Contrast residue was observed within the balloon chamber.A kink/twist was observed on the balloon chamber.The kink/twist is approximately 10.7mm proximal from the distal tip.No abnormality was noted on the distal tip.The two pacific xtreme devices returned exhibited twist on their respective balloon chamber.Both devices were returned within a post inflation profiles, an indication the devices were twisted during procedure.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 10498634
• Report Number: 9612164-2020-03346
• Device Sequence Number: 304256
• Product Code: LIT
• UDI-Device Identifier: 08033477075853
• UDI-Public: 08033477075853
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 10/29/2020

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: 02/27/2023
• Device Model Number: PCU060200130
• Device Catalogue Number: PCU060200130
• Device Lot Number: 219598484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1