MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT PACIFIC; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number PCF05012013P

Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)

Patient Problems Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199)

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician intended to use an in.Pact pacific with a 6f non-medtronic sheath and non-medtronic guidewire for treatment of a 100mm calcified lesion in the patients mid left superficial femoral artery of diameter 5mm.The lesion was reported to exhibit 80% stenosis.No tortuosity but severe calcification was reported.A non-medtronic inflation device was used with saline water and contrast.The ifu was followed and the device was prepped without issue.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device.It was reported that a balloon twist occurred.A rewrap tool was not used and no rewrap issue was noted.A new in.Pact pacific device was used to complete the procedure.No patient injury was reported.Please note that this device in.Pact pacific pta balloon catheter is not marketed in the united states; however, it is similar to the united states marketed device in.Pact admiral pta balloon catheter.

Manufacturer Narrative

Product analysis: the in.Pact pacific was returned for evaluation.A visual and a tactile inspection was carried out on the returned device and a twist was found in the middle of the balloon.No further issues were detected.During the analysis a purging test was performed.Negative pressure was applied with a manometric syringe on the balloon: no bubbles emerged in the water column.The balloon was inflated at 2 bar, 4 bar, 7 bar and 14 bar.2 bars: many wrinkles were present, with a visible change in profile in correspondence with the twisted point.A twist was detectable on the guidewire lumen.4 bars: the change in profile was still visible.Less wrinkles were visible on the balloon.7 bars: wrinkles and the change in profile were no longer visible.14 bars: no issue was noticed on the balloon surface.The twist on the guidewire lumen was clearly visible.After the inflation test, the balloon was deflated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT PACIFIC
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7689104
• MDR Text Key: 114548875
• Report Number: 9612164-2018-01740
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2020
• Device Catalogue Number: PCF05012013P
• Device Lot Number: 0008873829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 08/01/2018; 08/08/2018
• Supplement Dates FDA Received: 08/29/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1