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

Model Number ATG80142

Device Problems Break (1069); Inflation Problem (1310); Difficult to Remove (1528); Unraveled Material (1664); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2023

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 12/2025).

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate and had difficulty in retracting the device from the sheath.It was further reported that the balloon was shaped weird and allegedly detached.Reportedly, the device had some hair strings around the balloon.There was no reported patent injury.

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 observed to be inverted with unraveling fibers, and detached from the catheter but still attached to the inner guidewire lumen that was completely exposed.The glue bullet was not seated in the correct position and marker bands were still present.No anomalies noted to the luers/y-body.No functional testing was performed due to the condition of the sample.Therefore, the investigation is confirmed for the reported unraveled material as unraveling fibers were noted on the device.The investigation is also confirmed for the identified break as the balloon was seen detached from the catheter at one end but still attached to the inner guidewire lumen.The investigation is also confirmed for the removal difficulty as the balloon was observed to be inverted, which would have occurred due to difficulty removing through the sheath.The investigation is inconclusive for the reported uneven inflation as no functional testing could be performed due to the condition of the returned device.The investigation is unconfirmed for the reported detachment as no complete detachment was noted on the device.A definitive root cause for the alleged uneven inflation, removal difficulty, unraveled material, detachment and identified break 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.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 Description

It was reported that during an angioplasty procedure, the pta balloon allegedly did not expand and the shape of the balloon was weird.It was further reported that there was difficulty in retracting the device thru the introducer sheath.Reportedly, the balloon allegedly detached and hair strings was noted around the balloon.There was no reported patent injury.

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 observed to be inverted with unraveling fibers, and detached from the catheter but still attached to the inner guidewire lumen that was completely exposed.The glue bullet was not seated in the correct position and marker bands were still present.No anomalies noted to the luers/y-body.No functional testing was performed due to the condition of the sample.Therefore, the investigation is confirmed for the reported unraveled material as unraveling fibers were noted on the device.The investigation is also confirmed for the identified break as the balloon was seen detached from the catheter at one end but still attached to the inner guidewire lumen.However, the investigation is inconclusive for the reported uneven inflation and removal difficulty as no functional testing could be performed due to the condition of the returned device.Additionally, the investigation is unconfirmed for the reported detachment as no complete detachment was noted on the device.A definitive root cause for the alleged uneven inflation, removal difficulty, unraveled material, detachment and identified break 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: 12/2025), g3, h6 (device, 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 Description

It was reported that during an angioplasty procedure, the pta balloon allegedly did not expand and the shape of the balloon was weird.It was further reported that there was difficulty in retracting the device thru the introducer sheath.Reportedly, the balloon allegedly detached and hair strings was noted around the balloon.There was no reported patent injury.

• Brand Name: ATLAS GOLD
• Type of Device: 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: 16483443
• MDR Text Key: 310855172
• Report Number: 2020394-2023-00139
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060731
• UDI-Public: (01)00801741060731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2023

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
• Device Operator: Health Professional
• Device Model Number: ATG80142
• Device Catalogue Number: ATG80142
• Device Lot Number: 93ZG0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/04/2023
• Supplement Dates Manufacturer Received: 03/16/2023; 06/06/2023
• Supplement Dates FDA Received: 04/01/2023; 06/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female