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	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2019
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 intended to use an inpact admiral dcb balloon to treat a slightly calcified, slightly tortuous l050% stenotic lesion in the left distal superficial femoral artery(sfa).The artery diameter and lesion length were reported to be 4mm & 200mm, respectively.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.The device was prepped without issue.A 6fr non-medtronic sheath and a spiderfx were used for the procedure.The device was inflated with a non-medtronic inflation device and 50/50 contrast/saline solution was used as inflation fluid.The device did pass through a previously deployed stent - no resistance was encountered nor excessive force used on advancing the device to the target lesion.It was reported that there was a pinhole leak noted in the balloon when inflating it slowly up to 8atms.A new balloon was used to successfully complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: the device was prepped as per ifu with no issues identified.The device was removed from the patient with no issues noted.A new inpact admiral was used to successfully complete the procedure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis #703203281:device decontaminated with cidex-opa and tergazyme soak pending further testing to support the final product analysis findings.Blood and residue were visible within the balloon and catheter shaft.The device failed negative prep.Upon pressurization of the device, a pin-hole leak was observed in the distal balloon material.Damage and scratches were evident to the balloon material distal to the pin-hole leak.The balloon material was slightly jagged and uneven within the leak site.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: 8703173
• Report Number: 9612164-2019-02366
• Device Sequence Number: 2091228
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2019

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: 11/29/2021
• Device Catalogue Number: ADM04015013P
• Device Lot Number: 0009458036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 06/29/2019; 07/18/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/09/2019; 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1