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

Catalog Number PCF05012009P

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an inpact pacific balloon catheter was prepped as per the ifu with no issues identified.It was reported that a balloon twist occurred when treating an sfa lesion.A new balloon was used to complete the procedure.No patient injury was reported.Please note that this device (inpact pacific balloon catheter ) is not marketed in the united states; however, it is similar to the united states marketed device (inpact admiral balloon catheter ).

Manufacturer Narrative

Evaluation summary: the device was returned for evaluation.A visual and a tactile inspection was carried out on the returned device: a twist was found in the middle of the balloon.No further issues were detected.0,018¿¿ guidewire successfully passed.During the analysis, negative pressure was applied with a manometric syringe on the balloon: the purging test passed since no bubbles emerged in the water column.Afterwards, the balloon was inflated at: - 2 bars: many wrinkles were present, with a visible change in profile corresponding to the position of the twist - 4 bars: the change in profile was still visible.Less wrinkles on the balloon.¿ 7,14 bars: wrinkles and the change in profile were no longer visible.After the inflation test, the balloon was successfully deflated.Signs of twist were still visible after deflation.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: 7766712
• MDR Text Key: 116872448
• Report Number: 9612164-2018-01996
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/02/2018

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: 01/24/2021
• Device Catalogue Number: PCF05012009P
• Device Lot Number: 0008968312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 08/24/2018; 08/08/2018
• Supplement Dates FDA Received: 09/21/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• 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