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

Model Number 436-2012X

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 08/23/2021

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.(expiry date: 04/2022).Device pending return.

Event Description

It was reported that during preparation for angioplasty procedure, the tip of the pta balloon was allegedly broken.The procedure was completed by using another device.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination, therefore a device history record review is not required.Investigation summary: the sample was returned to the manufacturer for evaluation.The result of the investigation is unconfirmed for the reported tip break issue.The tip of the returned device was undamaged and intact.The evaluation of the returned device did confirm a detachment.The device outer was detached from the balloon at the proximal bond.The sleeve was not returned.The root cause for the reported tip break issue could not be determined based upon the available information received from the field communications and device evaluation.Labeling review: the instruction for use for the savvy long product was reviewed and contains the following information relevant to the reported event: warnings: visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is opened or damaged.Precautions: carefully inspect the catheter prior to use to verify that the catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Inspection and preparation: note: a 0.018¿ (0.457 mm) guidewire must be inserted in the savvy® long catheter across the balloon during any inflation of the balloon.Remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve while holding the catheter as close to the balloon as possible.If any resistance is felt, or if any stretching of the catheter is observed while removing the balloon sleeve, the product should not be used.The catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.Prepare a mixture of contrast medium and normal saline as per normal procedure.(recommended 25%/75%).Attach a stopcock and a 20 ml syringe half filled with the contrast solution to the balloon port.Point the syringe nozzle downward and aspirate until all air is removed from the balloon.Turn the stopcock off and maintain the vacuum in the balloon.Purge the catheter through lumen thoroughly.Reinserting the balloon into the balloon sleeve may damage the balloon or catheter.H10: d4 (expiry date: 04/2022).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 preparation for angioplasty procedure, the tip of the pta balloon was allegedly broken.The procedure was completed by using another device.There was no patient contact.

• Brand Name: SAVVY LONG 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: 12497505
• MDR Text Key: 272269206
• Report Number: 9616666-2021-00146
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741132674
• UDI-Public: (01)00801741132674
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 436-2012X
• Device Catalogue Number: 436-2012X
• Device Lot Number: CMDS0475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 70