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

Model Number	436-2512X
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 436-2512x savvy long otw pta catheter experienced material rupture.Of this event, the device was used on the patient with no reported injury.The age, weight, and sex were not provided.The 436-2512x savvy long otw pta catheter was never returned to the manufacturer for evaluation.With this data, the investigation is inconclusive for the reported failures.A definitive root cause could not be determined.The device is labelled for single use.
Additional Manufacturer Narrative
H.10.For the reported event, the result of the investigation is unconfirmed for the reported catheter rupture failure mode issue.There was a kink noted on the inner and outer at the exit of the strain relief.The method of packaging may have contributed to this.The kinks were unlikely to have been manufacturing related as catheters are 100% visually inspected for visual defects during manufacture.A definitive root cause could not be determined.The device is labelled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 436-2512x savvy long otw pta catheter experienced retraction issues and material rupture.The device was used on the patient with no reported injury.The age, weight, and sex were not provided.

• Brand Name: SAVVY LONG OTW PTA CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford AZ ; EI
• MDR Report Key: 8532944
• Report Number: 9616666-2019-00043
• Device Sequence Number: 19207850
• Product Code: LIT
• UDI-Device Identifier: 00801741132797
• UDI-Public: (01)00801741132797
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: No Information
• Device Model Number: 436-2512X
• Device Catalogue Number: 436-2512X
• Device Lot Number: CMBZ0298
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1