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

Catalog Number	AT75164
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly leaked during inflation at 14 atm.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2025) h11: section a through f ¿ the information provide by bd represents all 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: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.Two photos were reviewed.Both photos show the balloon being coiled into a package and placed over the outer package of catheter and the product details can be verified with the reported details.The balloon was clean and in deflated condition, no significant evidence of balloon rupture was noted on the device from the submitted photos.As no significant evidence of balloon rupture was noted on the device from the submitted photos, the investigation remains inconclusive to reported balloon rupture.A definitive root cause for the reported balloon rupture could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 12/2025), g3, h6 (method).H11: section a through f ¿ the information provide by bd represents all 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
It was reported that during an angioplasty procedure, the pta balloon allegedly leaked during inflation at 14 atm.The procedure was competed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly leaked during inflation at 14 atm.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one atlas pta dilatation catheter received for evaluation.During visual analysis fiber disturbance and stretching could be observed in the distal end of balloon.No other anomalies were noted.On functional testing in-house presto inflation device used for inflation and observed water leak in distal end of balloon.Further the balloon fiber were stripped and underwent to microscopic analysis could identified a compound rupture in distal end of balloon.No other testing was performed.Two photos were reviewed.Both photos show the balloon being coiled into a package and placed over the outer package of catheter and the product details can be verified with the reported details.The balloon was clean and in deflated condition, no evidence of balloon rupture was noted on the device from the submitted photos.Based visual analysis fiber disturbance, stretching in balloon, further on functional testing water leak and in microscopic analysis a compound rupture could be identified.Therefore the investigation was confirmed for the identified balloon fiber disturbance, stretching and reported balloon rupture.A definitive root cause for the identified balloon fiber disturbance, stretching and reported balloon rupture could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 12/2025), g3, h2, h6 (device).H11: h6 (method, result).H11: section a through f ¿ the information provided by bd represents all 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
It was reported that during an angioplasty procedure, the pta balloon allegedly leaked during inflation at 14 atm.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one atlas pta dilatation catheter received for evaluation.During visual analysis fiber disturbance and stretching could be observed in the distal end of balloon.No other anomalies were noted.On functional testing in-house presto inflation device used for inflation and observed water leak in distal end of balloon.Further the balloon fiber were stripped and underwent to microscopic analysis could identified a compound rupture in distal end of balloon.No other testing was performed.Two photos were reviewed.Both photos show the balloon being coiled into a package and placed over the outer package of catheter and the product details can be verified with the reported details.The balloon was clean and in deflated condition, no evidence of balloon rupture was noted on the device from the submitted photos.Based visual analysis fiber disturbance, stretching in balloon, further on functional testing water leak and in microscopic analysis a compound rupture could be identified.Therefore the investigation was confirmed for the identified balloon fiber disturbance, stretching and reported balloon rupture.A definitive root cause for the identified balloon fiber disturbance, stretching and reported balloon rupture could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date), g3.H11: section a through f ¿ the information provided by bd represents all 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: ATLAS
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18291354
• Report Number: 2020394-2023-01182
• Device Sequence Number: 6667593
• Product Code: DQY
• UDI-Device Identifier: 00801741062469
• UDI-Public: (01)00801741062469(11)230112(17)251228(10)GFGZ0091
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K120971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/20/2024

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: Health Professional
• Device Expiration Date: 12/28/2025
• Device Catalogue Number: AT75164
• Device Lot Number: GFGZ0091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/18/2024; 06/06/2024; 06/13/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/22/2024; 06/14/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown