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

Catalog Number	ADM04015013P
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2018
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
It was reported that the physician used an in.Pact admiral with a 6 fr non-medtronic sheath and spider fx embolic protection device for the treatment of a 100mm lesion in the patient's distal left superficial femoral artery <(>&<)> popliteal artery.The vessel was noted to have a diameter of 4mm, of little tortuosity and calcification of 20%.The target lesion (distal sfa) exhibited 90% stenosis prior to directional atherectomy, using a hawk, leaving 20-30% residual stenosis.A non-medtronic inflation device was used with 70/30 contrast ns.The ifu was followed and the device was prepped without issue.Negative pressure was performed before inflating.The balloon was inflated to a pressure of 8atms and it was noted the balloon would not remain inflated.A new in.Pact admiral device of the same size was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis: the device was returned for evaluation.Visual and tactile inspections were performed on the device.Dry blood was found on the device and also inside the inflation lumen.The balloon was unfolded.It was impossible to flush the device or insert the 0,035¿¿ guidewire due to the presence of dried blood.Negative pressure was applied to the balloon and the purging procedure failed.An attempt to inflate the balloon was made but a pinhole was detected and it was not possible to maintain the pressure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7595410
• Report Number: 9612164-2018-01415
• Device Sequence Number: 16187486
• Product Code: ONU
• UDI-Device Identifier: 00643169576315
• UDI-Public: 00643169576315
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 10/05/2018

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: 12/12/2020
• Device Catalogue Number: ADM04015013P
• Device Lot Number: 0008918291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 08/08/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/19/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 59