MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX PTA DILATATION CATHETER

Model Number	425-3022X
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional 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.Expiry date 06/2021).
Event or Problem Description
It was reported that the pta balloon catheter allegedly had material deformation.Therefore, another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the first reported complaint for this lot number and this issue to date.Investigation summary: the result of the investigation is inconclusive for the material deformation issue reported.The device was not returned for evaluation.The definitive root cause for the reported material deformation issue could not be determined based upon available information.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.It is unknown if patient factors, handling or procedural techniques contributed to the reported event.Labeling review: ifu for sleek pta rapid exchange (rx) dilatation catheter product family was reviewed the following sections are applicable: description: ¿ a 0.014¿ (0.356 mm) guidewire is recommended for use with the sleek® catheters.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 directions for use: inspection and preparation ¿ 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.D4 (expiry date 06/2021).
Event or Problem Description
It was reported that the pta balloon catheter allegedly had material deformation identified as kinked/twisted during use.Therefore, another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that the pta balloon catheter allegedly had material deformation identified as kinked/twisted during use.Therefore, another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the first reported complaint for this lot number and this issue to date.Investigation summary: the result of the investigation is confirmed for the material deformation issue reported.A kink was noted on the inner at the proximal cone and there was some minor twisting noted in the balloon.It is unlikely however that the observed defects are manufacturing related.A 100% visual inspection is performed during catheter production and a guide wire check is also performed on all devices.The definitive root cause for the reported material deformation issue could not be determined based upon available information.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.It is unknown if patient factors, handling or procedural techniques contributed to the reported event.Labeling review: ifu for sleek pta rapid exchange (rx) dilatation catheter product family was reviewed the following sections are applicable: description: ¿ a 0.014¿ (0.356 mm) guidewire is recommended for use with the sleek® catheters.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 directions for use: inspection and preparation ¿ 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.(expiry date 06/2021).

• Brand Name: SLEEK RX PTA DILATATION CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8223733
• Report Number: 9616666-2018-00186
• Device Sequence Number: 263905
• Product Code: LIT
• UDI-Device Identifier: 00801741132483
• UDI-Public: (01)00801741132483
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 425-3022X
• Device Catalogue Number: 425-3022X
• Device Lot Number: CMCU0548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 02/05/2019; 02/22/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/05/2019; 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1