MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS

Model Number	ADM05025013P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During the index procedure two in.Pact admiral balloon catheters were used to treat the right proximal, middle and distal superficial femoral artery (r1).During the procedure the patient suffered from a type b dissection in the proximal and mid sfa.It was confirmed that the dissection was caused by both dcbs.It was also stated that dcb lot number 0011091247 (pli20) also had a geographic miss.The event was treated with provisional stenting.The patient recovered.The procedural results showed good inflow and outflow with no perforation.The ae was assessed as not related to an underlying condition or disease.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15713333
• Report Number: 9612164-2022-04009
• Device Sequence Number: 6620219
• Product Code: ONU
• UDI-Device Identifier: 00643169975071
• UDI-Public: 00643169975071
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2025
• Device Model Number: ADM05025013P
• Device Catalogue Number: ADM05025013P
• Device Lot Number: 0011091247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 11/02/2022
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic