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

Catalog Number	ADM06015013P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
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
The physician intended to use the inpact admiral with a spider fx 7.0, non-medtronic inflation device and a non-medtronic 7f sheath, to treat a moderately calcified 140mm, 99% stenosed fibrous/plaque lesion in the right superficial femoral artery of diameter 6.5mm.Moderate tortuosity are reported.The device was prepped as per ifu with no issues identified.It was reported no resistance was encountered advancing the admiral.During removal of the inpact admiral the balloon was caught inside the 7f sheath.The sheath was removed from the patient the balloon remained inside the sheath.A trailblazer was used to remove the spider fx.The physician reported that he always uses a trailblazer to retrieve filters therefore no alleged complaint against the spider.All components were removed from the patient.The sheath was replaced with a 7fr sheath to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the device was returned for evaluation.The data on the luer and labels was consistent with the lot number indicated in the product complaint form.Visual and tactile inspections were performed on the device and traces of blood were detected on the surface.Only the proximal part of the catheter was provided (hub and shaft).The balloon and guidewire tube underneath the balloon, together with the markers were missing.The distal part of the shaft was found stretched.Further tests were not allowed due to the device conditions.An angio image was also provided showing angiography of the vessel.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8089617
• Report Number: 9612164-2018-03282
• Device Sequence Number: 1359050
• Product Code: ONU
• UDI-Device Identifier: 00643169576353
• UDI-Public: 00643169576353
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140010
• 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): 12/13/2018

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: 01/08/2021
• Device Catalogue Number: ADM06015013P
• Device Lot Number: 0008945724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 115