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

Model Number AT75144

Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 04/24/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly wouldn't deflate.It was further reported that the device was allegedly difficult to be removed.There was no reported patient injury.

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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 12/2025).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.

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 pta dilatation catheter was returned for evaluation.The balloon was loaded in an unknown sheath.The balloon had a break from the catheter leaving the portholes and some part of the inner guide wire lumen was exposed.The balloon was still attached to the catheter, not completely detached and was completely bunched near to the distal end.No other anomalies were noted during the visual evaluation.During the functional testing, an attempt to remove the loaded sheath was performed but was unsuccessful.However, the balloon was completely advanced throughout the sheath, exposing the inner guidewire lumen and glue bullet seated incorrectly.Also, two photos were provided and reviewed.The first photo shows the balloon loaded within the introducer sheath and the balloon was not to be bunched near the distal end of the distal tip.The second photo shows the bunched balloon material.No other anomalies are noted in the submitted photo.Based on the returned sample and photos, the returned catheter was loaded within an unknown sheath and had a break exposing the port holes and glue bullet.Therefore, the investigation was confirmed for the reported sheath removal issue and catheter break.However, the functional testing couldn¿t be performed for the deflation issue due to the device's condition being returned for evaluation.Hence remain the investigation will remain inconclusive for reported deflation issue.A definitive root cause for the reported sheath removal issue and catheter break and reported deflation issue 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: b5, h6 (result, conclusion) 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 : see h10.

Event Description

It was reported that during an angioplasty procedure, the balloon allegedly wouldn't deflate.It was further reported that physician need to upsize the sheath to get the balloon out.Reportedly, the balloon was separating from the plastic.The physician had to to access another area in the fistula to finish the procedure.There was no reported patient injury.

• Brand Name: ATLAS
• Type of Device: 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: 16959796
• MDR Text Key: 315564965
• Report Number: 2020394-2023-00348
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120971
• 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
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AT75144
• Device Catalogue Number: AT75144
• Device Lot Number: GFGZ1212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• 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