MAUDE Adverse Event Report: INVATEC TECHNOLOGY CENTER GMBH IN.PACT PACIFIC; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number PCF05012009P

Device Problems Deflation Problem (1149); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 Description

It was reported that a physician was attempting to use an in.Pact pacific paclitaxel-eluting pta balloon catheter to treat a lesion in a patient in the sfa with no tortuosity.The device was removed from packaging and prepped with no issues noted.It was reported that the device would not deflate at the lesion site and balloon twisting occurred during inflation.Another in.Pact pacific device was used and the procedure was completed successfully.No patient injury or clinical sequelae reported for this event.¿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.¿.

Manufacturer Narrative

Image review: angio image was provided for evaluation.The angio image showed inflated balloon with a point of constriction.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.

Manufacturer Narrative

Device evaluation: a visual and tactile inspections were performed: the balloon was found unfolded while no traces of radiopaque liquid or clotted blood were found inside the inflation lumen or guide wire lumen.An evident twist was found on the balloon at 8,5 cm from the proximal balloon welding.It was possible to easily insert the 0,018¿¿ guide wire after flushing without any resistance.A purging procedure was executed and no issues were found.Afterwards, the balloon was inflated sequentially at: - 1 bar: wrinkles were noted on the balloon, in correspondence of the balloon twist detected and balloon profile deformed; - 2 bar: the balloon continued showing some wrinkles and profile deformations; - 4 bar: some wrinkles on the balloon were still visible.It was also visible a slight twist on the guide wire lumen, in correspondence of the twisting point.Same situation increasing pressure up to 7 bar (nominal pressure).No issues detected during deflation.Once deflated the wrinkles close to the twisting point became visible again continued from block.Operational problem - the root cause is related to the direction of the folding pleats which appear not to be folded parallel to the shaft of the device.Once inside the artery, the folding pleats most likely encounter resistance related to a tight lesion, resulting an incomplete balloon expansion.

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): INVATEC TECHNOLOGY CENTER GMBH; hungerbuelstrasse 12; frauenfeld ; CH
• Manufacturer (Section G): INVATEC TECHNOLOGY CENTER GMBH; hungerbuelstrasse 12; frauenfeld ; CH
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5570430
• MDR Text Key: 42428726
• Report Number: 3004066202-2016-00105
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: PCF05012009P
• Device Lot Number: 2F019019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/27/2016
• Supplement Dates FDA Received: 06/16/2016; 07/21/2016; 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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
• Patient Age: 00057 YR