MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. BANTAM OTW PTA CATHETER; PTA BALLOON DILATATION CATHETER

Catalog Number 48522050

Device Problems Inflation Problem (1310); Material Rupture (1546); Material Twisted/Bent (2981)

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

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images and videos were provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the savvy long pta dilatation catheter products that are cleared in the us.The pro code and 510 k number for the savvy long pta dilatation catheter products are identified.(expiry date: 01/2023).

Event Description

It was reported that during an angioplasty procedure, the balloon allegedly ruptured in the middle portion.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be not-reportable.H10: as the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending; however, images and videos were provided for review.The investigation of the reported event is currently underway.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the savvy long pta dilatation catheter products that are cleared in the us.The pro code and 510 k number for the savvy long pta dilatation catheter products are identified in d2 and g5.H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that during an angioplasty procedure through superficial femoral artery, there was an alleged inflation issue and balloon torsion noted at 6atm.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: BANTAM OTW PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 10948588
• MDR Text Key: 230670949
• Report Number: 9616666-2020-20025
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48522050
• Device Lot Number: CMEP0216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR