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

Model Number	ATG120144
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2024).
Event or Problem Description
It was reported that during an angioplasty procedure in the right brachiocephalic vein, the pta balloon allegedly burst at 7 atm and detached from the catheter within the subclavian vein.It was further reported that physician attempted to loop and remove the balloon by accessing the brachial vein using foreign body rescue handle; however, the balloon was unable to be removed.Reportedly, the pta balloon was removed using urology forceps through the introducer sheath by puncturing the site in the right basilica vein.The procedure was completed using another device.Patient reported as stable.
Event or Problem Description
It was reported that during an angioplasty procedure in the right brachiocephalic vein, the pta balloon allegedly ruptured at 7 atm and detached from the catheter within the subclavian vein.It was further reported that physician attempted to loop and remove the balloon by accessing the brachial vein using foreign body rescue handle; however, the balloon was unable to be removed.Reportedly, the pta balloon was removed using urology forceps through the introducer sheath by puncturing the site in the right basilica vein.The procedure was completed using another device.Patient reported as stable.
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: the physical device was not returned for evaluation.Two photos were provided and reviewed.The first photo shows the atlas gold pta dilatation catheter.The balloon is noted to be detached from the catheter.The second photo shows the detached balloon which is noted to be bloody.No other specific anomalies are noted.Therefore the investigation is confirmed for balloon detachment as the balloon is noted to be detached from the catheter.However, the investigation is inconclusive for balloon rupture as no evidence of rupture can be seen.A definitive root cause for the alleged balloon rupture and balloon detachment could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Two photos were provided and reviewed.The first photo shows the atlas gold pta dilatation catheter with the balloon detached from it.The second photo shows the detached balloon which is noted to be bloody.No other specific anomalies noted.Therefore, the investigation is confirmed for the reported balloon detachment as the balloon was noted to be detached from the catheter from the provided photo.However, the investigation is inconclusive for the reported balloon rupture and retrieval difficulty as no evidence of the failures could be determined.A definitive root cause for the alleged balloon rupture, balloon detachment and retrieval difficulty could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 03/2024), g3, h6 (device).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
It was reported that during an angioplasty procedure in the right brachiocephalic vein, the pta balloon allegedly ruptured at 7 atm and detached from the catheter within the subclavian vein.It was further reported that physician attempted to loop and remove the balloon by accessing the brachial vein using foreign body rescue handle; however, the balloon was unable to be removed.Reportedly, the pta balloon was removed using urology forceps through the introducer sheath by puncturing the site in the right basilica vein.The procedure was completed using another device.Patient reported as stable.
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 was received for evaluation.During visual evaluation, the balloon was noted detached from the catheter leaving the inner guidewire lumen exposed.The glue bullet was seen seated in the incorrect position.No functional testing was performed due to the condition of the sample.Two photos were provided and reviewed.The first photo shows the atlas gold pta dilatation catheter with the balloon detached from it.The second photo shows the detached balloon which is noted to be bloody.No other specific anomalies noted.Therefore, the investigation is confirmed for the reported balloon detachment as the balloon was noted to be detached from the catheter from both the photo review and the returned sample.However, the investigation is inconclusive for the reported balloon rupture and retrieval difficulty as no evidence of the failures could be determined.A definitive root cause for the alleged balloon rupture, balloon detachment and retrieval difficulty could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure in the right brachiocephalic vein, the pta balloon allegedly ruptured at 7 atm and detached from the catheter within the subclavian vein.It was further reported that physician attempted to loop and remove the balloon by accessing the brachial vein using foreign body rescue handle; however, the balloon was unable to be removed.Reportedly, the pta balloon was removed using urology forceps through the introducer sheath by puncturing the site in the right basilica vein.The procedure was completed using another device.Patient reported as stable.

• 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: 13109175
• Report Number: 2020394-2021-02123
• Device Sequence Number: 4589125
• Product Code: DQY
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATG120144
• Device Catalogue Number: ATG120144
• Device Lot Number: 93PF0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 03/15/2022; 10/19/2022; 02/15/2023
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 03/17/2022; 10/25/2022; 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male