MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA CATHETER PTA BALLOON DILATATION CATHETERS

Model Number 436-3015X

Device Problems Material Rupture (1546); Difficult to Advance (2920); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed. The return of the sample is pending. The investigation of the reported event is currently underway. Device pending return.

Event Description

It was reported that during an angioplasty procedure in the lower extremity arteriosclerosis via a moderately calcified lesion to treat the femoral popliteal segment and the superficial segment of the femur, the pta balloon was allegedly difficult to reach the lesion and it was further reported that the balloon ruptured at 12 atm. The procedure was completed using another device. There was no reported patient injury.

• Brand Name: SAVVY LONG OTW PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETERS
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13730156
• MDR Text Key: 287016390
• Report Number: 9616666-2022-00046
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 436-3015X
• Device Catalogue Number: 436-3015X
• Device Lot Number: CMDT0238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial