MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER; PTA BALLOON DIALATION CATHETER

Model Number	ATG120244
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is being returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg120244 pta balloon dilatation catheter allegedly experienced a retraction problem and rupture.There was one patient involved with no reported patient injury.This information was received from one source.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg120244 pta balloon dilatation catheter allegedly experienced a retraction problem and rupture.There was one patient involved with no reported patient injury.This information was received from one source.Patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot history review was performed.The device was returned for evaluation.The investigation identified the pta dilatation catheter was stuck in a introducer sheath.The balloon was also observed to be detached from the glue joint.Therefore, retraction issues and detachment were identified.The rupture was not identified.A root cause has not been determined.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.
Additional Manufacturer Narrative
H10: the lot history review was performed.The device was returned for evaluation.The investigation identified the pta dilatation catheter was stuck in a introducer sheath.The balloon was also observed to have a break at the glue joint.Therefore, retraction issues and a break were identified.The rupture was not identified.A root cause has not been determined.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 atg120244 pta balloon dilatation catheter allegedly experienced a retraction problem and rupture.There was one patient involved with no reported patient injury.This information was received from one source.Patient age, weight, and gender were not provided.

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DIALATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8808057
• Report Number: 2020394-2019-01616
• Device Sequence Number: 18912230
• Product Code: DQY
• UDI-Device Identifier: 00801741061028
• UDI-Public: (01)00801741061028
• 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,Followup
• Report Date (Section B): 10/21/2019

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: ATG120244
• Device Catalogue Number: ATG120244
• Device Lot Number: 93ND0177
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 10/17/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 10/10/2019; 10/21/2019
• Patient Sequence Number: 1