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
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 08/2021).
Event or Problem Description
It was reported that as the healthcare professional (hcp) was using the pta balloon catheter it allegedly had material deformation.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 only complaint that has been reported for this corporate lot number to date.Investigation summary: the result of the investigation is confirmed for the material deformation failure mode reported.The evaluation noted 2 kinks, on the inner and the transition outer.There were also 5 minor bends noted along the shaft length and a solidified blood blockage 80mm from the distal tip.It is unlikely that the kinks and bends are manufacturing related, as a 100% visual inspection for catheter defects is performed during manufacture.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.Finally it is unknown whether 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.H10: d4 (expiry date 08/2021); g4.H11: h3; h6 (method 1, results 1, conclusion 1).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 or Problem Description
It was reported that as the healthcare professional (hcp) was using the pta balloon catheter it allegedly had material deformation.There was no reported patient injury.

• 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: 8222827
• Report Number: 9616666-2018-00185
• Device Sequence Number: 18881251
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: CMCW0169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1