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

Catalog Number	PCF06008009P
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Physician was attempting to treat a moderately calcified lesion in the sfa to popliteal using in pact admiral paclitaxel eluting balloon catheter.It was alleged that a balloon twist was noted during inflation.Procedure was completed with another balloon.There was no injury to patient.
Additional Manufacturer Narrative
Device evaluation: a visual and a tactile inspection was carried out on the device returned: dry blood was found on the device but no issue detected.The balloon was unfolded and dirty of blood.The inspection of the device did not report any abnormality on the device.The device was flushed and a 0.018¿ guide wire was successfully advanced from the tip to the hub of the device without issue.Then, the balloon was inflated and no issue or sign or twist were detected.The defect was initial reported against the in.Pact admiral balloon catheter.However, the actual device involved in the allegation is an in.Pact pacific balloon catheter and same was returned for evaluation.¿please note that this device (in.Pact pacific) is not marketed in the united states; however, it is similar to the united states marketed device (in.Pact admiral).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.¿ 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.
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: 6463297
• Report Number: 9612164-2017-00379
• Device Sequence Number: 10907662
• Product Code: ONU
• UDI-Device Identifier: 00643169383289
• UDI-Public: 00643169383289
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2017

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: 08/26/2019
• Device Catalogue Number: PCF06008009P
• Device Lot Number: 0008196396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided; 04/20/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 05/11/2017; 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1