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

Model Number	436-2515L
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
For the reported malfunction, the return of the device is pending.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 436-2515l pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.One patient was involved with no reported patient injury.Patient age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 436-2515l pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.One patient was involved with no reported patient consequences.Patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction was provided, therefore a lot history review was performed.The sample was returned for evaluation.After further evaluation, the investigation confirmed for the material rupture issue reported.A kink was also identified on both the inner and the outer at the exit of the strain relief.The definitive root cause is unknown.The device is labeled for single use.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.

• Brand Name: SAVVY LONG OTW 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: 9211456
• Report Number: 9616666-2019-00132
• Device Sequence Number: 305189
• Product Code: LIT
• UDI-Device Identifier: 00801741132803
• UDI-Public: (01)00801741132803
• 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): 01/06/2020

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: 436-2515L
• Device Catalogue Number: 436-2515L
• Device Lot Number: 50142830
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1