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

Model Number	436-2012X
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records is not required as there were no other complaints identified for this lot number.The result of the investigation is confirmed for the material rupture issue reported.There were 3 pinholes noted in the balloon during evaluation.There was also a kink noted on the inner and outer at the exit of the strain relief.It is unlikely that the kink is manufacturing related as a 100% visual inspection for catheter defects is performed.The definitive root cause for the reported material rupture issue could not be determined based upon available information.The device is labeled for single use.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
This report summarizes one malfunction.A review of the reported information indicated that model 436-2012x.Pta dilatation catheter allegedly had a pinhole rupture at 12atm.It was further reported that another dilatation catheter was used to complete the procedure.This report was received from a single source.This event did involve patient with no reported patient injury.The patient is (b)(6) of age, the gender is male, and the weight is (b)(6).

• Brand Name: SAVVY LONG OTW PTA CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8783288
• Report Number: 9616666-2019-00079
• Device Sequence Number: 13911523
• Product Code: LIT
• UDI-Device Identifier: 00801741132674
• UDI-Public: (01)00801741132674
• 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
• Report Date (Section B): 07/11/2019

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: 436-2012X
• Device Catalogue Number: 436-2012X
• Device Lot Number: CMBX0246
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/11/2019
• Patient Sequence Number: 1