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

Model Number	425-2512X
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The investigation of the reported event is currently underway.(expiry date: 06/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the proximal catheter end allegedly broke during removal from the patient.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was returned for evaluation.The result of the investigation is confirmed for the reported break issue.There was a break observed in the hypotube 135mm from the hub.The investigation was inconclusive for the retraction problem.There was no sheath returned and the device was returned in two parts.The definite root cause could not be determined based upon the available information.Labeling review: the instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.H10: d4 (expiry date: 06/2023).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 or Problem Description
It was reported that during an angioplasty procedure, the proximal catheter end allegedly broke.It was further reported that the device allegedly had retraction issue when removing form the patient.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: SLEEK RX PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 11162515
• Report Number: 9616666-2020-20042
• Device Sequence Number: 3583707
• Product Code: LIT
• UDI-Device Identifier: 00801741132377
• UDI-Public: (01)00801741132377
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 425-2512X
• Device Catalogue Number: 425-2512X
• Device Lot Number: CMEU0679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other