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

Catalog Number	ATG120162
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
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 return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 09/2025).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.H3 other text : device pending return.
Event or Problem Description
It was reported that during an angioplasty procedure, when attempting to withdraw the balloon catheter through the introducer, the balloon allegedly would not re-enter the introducer and subsequently detached from the shaft and allegedly could not be removed.It was further reported that the introducer and balloon allegedly removed through the femoral vessel.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the right femoral artery, when attempting to withdraw the balloon catheter through the introducer, the balloon allegedly would not re-enter the introducer and subsequently detached from the shaft and allegedly could not be removed.It was further reported that the introducer and balloon were allegedly removed through the femoral vessel.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas gold pta dilatation catheter loaded into unknown introducer sheath was received for evaluation.During visual analysis, the balloon had broken from the proximal end of the catheter shaft exposing the inner guidewire lumen.No balloon detachment was noted and no other anomalies were noted.On the functional testing, an attempt was made to remove the sheath from the device which was failed.Further an inhouse guidewire was inserted into the catheter with slight resistance.No further testing was performed.Also, one photo was received and reviewed.In the provided photo one pta balloon catheter loaded into an unknown sheath was noted and balloon appeared to be in deflated condition.And the balloon was found to be broken from the proximal end of the catheter shaft exposing the inner guidewire lumen.No evidence of balloon detachment noted, no other anomalies were found.As the submitted photo and the return sample analysis confirms the evidence of balloon noted to be stuck within the unknown sheath and the balloon had a break from the proximal end of the catheter shaft, the investigation was confirmed for the reported balloon removal issue and identified balloon break from the catheter shaft.Since no evidence of balloon detachment was observed, the investigation was unconfirmed for the reported balloon detachment.A definitive root cause for the reported balloon removal issue, detachment and identified balloon break with the catheter 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.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 in the right femoral artery, when attempting to withdraw the balloon catheter through the introducer, the balloon allegedly would not re-enter the introducer and subsequently detached from the shaft and allegedly could not be removed.It was further reported that the introducer and balloon were allegedly removed through the femoral vessel.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas gold pta dilatation catheter loaded into unknown introducer sheath was received for evaluation.During visual analysis, the balloon had broken from the proximal end of the catheter shaft exposing the inner guidewire lumen.No balloon detachment was noted and no other anomalies were noted.On the functional testing, an attempt was made to remove the sheath from the device which was failed.Further an inhouse guidewire was inserted into the catheter with slight resistance.No further testing was performed.Also, one photo was received and reviewed.In the provided photo one pta balloon catheter loaded into an unknown sheath was noted and balloon appeared to be in deflated condition.And the balloon was found to be broken from the proximal end of the catheter shaft exposing the inner guidewire lumen.No evidence of balloon detachment noted, no other anomalies were found.As the submitted photo and the return sample analysis confirms the evidence of balloon noted to be stuck within the unknown sheath and the balloon had a break from the proximal end of the catheter shaft, the investigation was confirmed for the reported balloon removal issue and identified balloon break from the catheter shaft.Since no evidence of balloon detachment was observed, the investigation was unconfirmed for the reported balloon detachment.A definitive root cause for the reported balloon removal issue, detachment and identified balloon break with the catheter 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.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.

• Brand Name: ATLAS GOLD
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18368659
• Report Number: 2020394-2023-01307
• Device Sequence Number: 15395264
• Product Code: DQY
• UDI-Device Identifier: 00801741060809
• UDI-Public: (01)00801741060809(11)220909(17)250909(10)93WG0044
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181323
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2024

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: 09/09/2025
• Device Catalogue Number: ATG120162
• Device Lot Number: 93WG0044
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 04/09/2024; 06/12/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 04/16/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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 Age: 17 YR
• Patient Sex: Male
• Patient Weight: 83 KG