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

Catalog Number PCF050300130

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

Patient weight reported as (b)(6). If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a pacific xtreme device with a 6fr sheath and 0. 018 wire during treatment of a 30 cm lesion in the patients right full superficial femoral artery (sfa) and popliteal arteries of diameter 5 mm. Severe calcification is reported but no tortuosity. Crossover procedure. Lesion exhibited 90-100% stenosis. Embolic protection was not used. No damage noted to device or packaging prior to use. Ifu was followed. Device prepped without issue. The device was not passed through a previously deployed stent. No resistance was felt during advancement and not excessive force was used. A manometer was used with 50/50 fluid for balloon inflation. It is reported that 2 twists were evident on the balloon. The device was replaced with another pacific xtreme to complete the procedure. No patient injury reported.

Manufacturer Narrative

Image review: a single photograph of a cine image was received for analysis. The image is of a pta device within a vessel. Two balloon twists are present in the pta device. Product analysis: the pacific xtreme pta balloon catheter was received for evaluation. Two zones of witness marks from inflation twists were noted in the balloon chamber material. The twisting / ¿candy wrapper¿ is located 97mm and 157mm proximal of the catheter¿s distal tip. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the twist occurred during first inflation of the balloon. The device was safely removed from the patient. 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: 8991157
• Report Number: 9612164-2019-03868
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/14/2022
• Device Catalogue Number: PCF050300130
• Device Lot Number: 217704600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 51 YR