MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LITEPAC RX PTA CATHETER; PTA BALLOON DILATATION CATHETER

Catalog Number 68202086

Device Problems Inflation Problem (1310); Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.The catalog number identified in section has not been cleared in the us, but is similar to the sleek rx pta catheter products that are cleared in the us.The 510k number and pro code for the sleek rx pta catheter products are identified.

Event Description

It was reported that during treatment for left carotid artery occlusion via left carotid artery approach the pta dilatation catheter allegedly could not be fully dilated within the blood vessel.Reportedly, post device removal, separation was identified at the balloon's connection edge and deflation occurred.Reportedly, a new balloon was used to complete the procedure.The current patient status is unknown post procedure.

Manufacturer Narrative

H10: manufacturing review: a device history record review was no required, as no other complaints were identified for this lot number.Investigation summary: the result of the investigation is inconclusive for the balloon detachment and inflation issues reported.The sample was not returned for evaluation.The definitive root cause for the reported balloon detachment and inflation issues could not be determined based upon available information.The event description states that the litepac rx device was being used to treat an occlusion of the left carotid artery.This is off label use of the device.It is unknown if there were patient factors, handling or other procedural techniques that contributed to the reported event.Labeling review: the ifu (instructions for use) for the litepac rx product was reviewed and contains the following information relevant to the reported event: the event description states that the litepac rx device was being used to treat an occlusion of the left carotid artery.This is off label use of the device.The lite pac pta balloon catheters are intended for balloon dilatation of renal, iliac, and femoral arteries and for the treatment of obstructive lesions of native synthetic arteriovenous dialysis fistulae.H11: b5, d10, g1, h6(results, conclusion).H11:section a through f - the information provided by bd represents all of 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 treatment for left carotid artery occlusion via left carotid artery approach the pta dilatation catheter allegedly could not be fully dilated within the blood vessel.Reportedly, post device removal, separation was identified at the balloon's connection edge leading to deflation.Reportedly, a new balloon was used to complete the procedure.The current patient status is unknown post procedure.

• Brand Name: LITEPAC RX 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: 8884401
• MDR Text Key: 154017178
• Report Number: 9616666-2019-00091
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391509837507
• UDI-Public: (01)05391509837507
• 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: 10/08/2019

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 Catalogue Number: 68202086
• Device Lot Number: CMCY0202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 68 YR