MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR (BPV) ATLAS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	AT75186
Medical Device Problem Codes	Peeled/Delaminated (1454); Unraveled Material (1664); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided; therefore, a lot history review will be performed.The device was not returned to bd; however, one electronic photo was provided for evaluation.Therefore, the photo is pending evaluation.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 at75186 pta balloon dilatation catheter allegedly experienced fiber wrapped around the balloon and material deformation.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided; therefore, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation; however, two photos were provided for review.The investigation is confirmed for unraveled material and peeled.A definitive root cause for the reported event could not be 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 at75186 pta balloon dilatation catheter allegedly experienced fiber wrapped around the balloon and material deformation.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.

• Brand Name: ATLAS PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR (BPV)
• MDR Report Key: 10276480
• Report Number: 2020394-2020-04454
• Device Sequence Number: 14084883
• Product Code: DQY
• UDI-Device Identifier: 00801741062506
• UDI-Public: (01)00801741062506
• 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): 10/12/2020

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: AT75186
• Device Catalogue Number: AT75186
• Device Lot Number: GFEN2287
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/12/2020
• Patient Sequence Number: 1