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

Model Number	AT75164
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	02/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The investigation of the reported event is currently underway.(expiration date: 08/2024).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured in patient's central veins and catheter detached upon retrieval.It was further reported that the ruptured balloon was unable to retrieved completely through the introducer sheath.Reportedly, the patient undergone open surgery at the right axilla to get the device removed.The current patient status is unknown.
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: received one atlas pta dilatation balloon loaded onto an unknown guidewire and the detached catheter was not returned for evaluation.On visual evaluation, the balloon was removed from the guidewire.A complete circumferential break was noted to the inner guide-wire lumen.No other anomalies were noted.On functional testing, the returned balloon was examined under x-ray; the distal tip and one marker band were noted to the remaining inner guide-wire lumen.Therefore, the investigation for reported balloon rupture remains inconclusive as no evidence of rupture could not be noted and no functional testing was performed due to the condition of the device.The investigation for reported difficult to remove remains inconclusive as no functional testing was performed due to the condition of the device.However, the investigation was confirmed for the reported detachment as the balloon was noted to be detached from the catheter.And the detached remaining portion of the catheter and inner guide wire lumen were not returned.A definitive root cause for the reported balloon rupture, balloon detachment and difficult to remove 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: 08/2024).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, the pta balloon allegedly ruptured in the patient's central vein and the catheter got detached upon retrieval.It was further reported that the ruptured balloon was unable to be retrieved completely through the introducer sheath.Reportedly, the patient undergone open surgery at the right axilla and the device was removed.The current patient status is unknown.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13867527
• Report Number: 2020394-2022-00203
• Device Sequence Number: 14768365
• Product Code: DQY
• UDI-Device Identifier: 00801741062469
• UDI-Public: (01)00801741062469
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: AT75164
• Device Catalogue Number: AT75164
• Device Lot Number: GFFV1887
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/06/2022
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 55 KG