MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number PCF050300130

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

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

During an attempt to treat a lesion using pacific xtreme, it was reported that balloon twist occurred during use.No patient injury or clinical sequelae reported for this event.

Manufacturer Narrative

Results: 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 evaluation codes: conclusion: operational context caused or contributed to event - 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 device evaluation: a visual and tactile inspections were performed.A bubble in the luer bonding was detected and highlighted through a microscope.However it does not affect the device performance.No damages has been noted on the shaft.The balloon was used.A wrinkled area was noted on the balloon at approximately 15 cm form the proximal welding.The guide wire lumen was flushed and it was possible to insert the 0,018¿¿ guide wire without any resistance.The purging procedure was performed with no issues.The balloon was inflated at 1 bar and its profile resulted deformed in the point of twisting.The deformation disappeared increasing the inflating pressure over 4 bar.It was possible to note a deformation point on the guide wire tube just below the wrinkled area, identified as point of twist.No further issues found.

Manufacturer Narrative

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

• Brand Name: PACIFIC XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5885938
• MDR Text Key: 52421295
• Report Number: 9612164-2016-00865
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K103464
• 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: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: PCF050300130
• Device Lot Number: 210671568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• 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