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

Model Number	426-3022X
Medical Device Problem Codes	Break (1069); Deflation Problem (1149); Material Rupture (1546); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided, therefore a lot history review was performed.The sample was not returned and the investigation is inconclusive for the reported deflation issue and balloon rupture.The definitive root cause could not be determined based upon available information.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 426-3022x pta balloon dilatation catheter allegedly experienced deflation issue and balloon rupture.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided, therefore a lot history review was performed.The sample was returned for evaluation.Investigation is confirmed for device-device incompatibility, material deformation, and break, but is inconclusive for the reported deflation issue and balloon rupture.The definitive root cause could not be determined based upon available information.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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 426-3022x pta balloon dilatation catheter allegedly experienced deflation issue, balloon rupture, device-device incompatibility, material deformation, and break.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.

• Brand Name: SLEEK 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: 10715186
• Report Number: 9616666-2020-00096
• Device Sequence Number: 2949623
• Product Code: DQY
• UDI-Device Identifier: 00801741133787
• UDI-Public: (01)00801741133787
• 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): 04/20/2021

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: No Information
• Device Model Number: 426-3022X
• Device Catalogue Number: 426-3022X
• Device Lot Number: CMBY0396
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 04/20/2021
• Patient Sequence Number: 1