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	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
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 used an in.Pact admiral paclitaxel-eluting pta balloon catheter with an.014 gw, 6fr sheath and a non-mdt inflation device for the treatment of a slightly calcified plaque lesion in the proximal sfa.Lesion exhibited 50% stenosis.Embolic protection was not used.Device prepped as per ifu without issue.It was reported that the device would not deflate at the lesion site.This occurred after the balloon was successfully inflated 3 times for 3 minutes at each inflation.Physician successfully partially deflated the balloon and pulled it back through the sheath for removal from the patient.No other intervention was required.It was reported there were no patient complications as a result of this issue.
Additional Manufacturer Narrative
Device evaluation summary: the device was returned for evaluation.A visual and tactile inspections were performed on the device and no damage was found along the shaft length and balloon.Evident traces of dry radiopaque liquid were found in the inflation lumen.The balloon was found unfolded.The guide wire lumen was flushed and it was possible to insert the 0,035¿¿ guide wire without any resistance.Once cleaned the dry radiopaque solution, the purging procedure was performed with no issues.In order to verify the correct deflation time the balloon was inflated 3 times at rbp with radiopaque solution( radiopaque contrast/saline was 50/50).The deflation time was taken for 3 times and it was respectively 20 s, 22 s, 23 s.All the measurement taken were compliant with the maximum deflation time (i.E.Deflation time = 60s) reported in product performance specification/report.No abnormalities detected on the device.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: 7188557
• Report Number: 9612164-2018-00066
• Device Sequence Number: 10779107
• Product Code: ONU
• UDI-Device Identifier: 00643169576315
• UDI-Public: 00643169576315
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/21/2018

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: 08/09/2018
• Device Catalogue Number: ADM04015013P
• Device Lot Number: 0008152250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1