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

Catalog Number ATG120244

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problems Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 09/22/2023

Event Type  Injury  

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, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 10/2022).H11: section a through f ¿ the information provided 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 in the pulmonic valve via the right jugular vein access, during the first inflation prior to reaching the rated burst pressure, the pta balloon allegedly ruptured before or at 3 atm at most, and allegedly had a small pinpoint leakage in the distal shoulder of the balloon.It was further reported that the patient allegedly experienced pulmonary artery dissection and had a partial rupture of the pulmonary artery that caused pericardial infusion.Furthermore, the procedure was unable to be completed due to the risk of subsequent balloon inflations and the procedure was aborted for patient's safety.Reportedly, the patient was kept for forty-eight hours in the intensive care unit for close monitoring of the progressive pulmonary artery rupture and had activity restrictions at home for about two to four weeks.However, the patient was recovered well.

Event Description

It was reported that during an angioplasty procedure in the pulmonic valve via the right jugular vein access, during the first inflation prior to reaching the rated burst pressure, the pta balloon allegedly ruptured before or at 3 atm at most, and allegedly had a small pinpoint leakage in the distal shoulder of the balloon.It was further reported that the patient allegedly experienced pulmonary artery dissection and had a partial rupture of the pulmonary artery that caused pericardial infusion.Furthermore, the procedure was unable to be completed due to the risk of subsequent balloon inflations and the procedure was aborted for patient's safety.Reportedly, the patient was kept for forty-eight hours in the intensive care unit for close monitoring of the progressive pulmonary artery rupture and had activity restrictions at home for about two to four weeks.However, the patient was recovered well.

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.No kinks were noted to the catheter, no anomalies noted to the y-body/strain relief.The balloon appeared partially inflated.An in-house presto inflation device was used to inflate the balloon and a pinhole rupture was noted on the balloon.No other functional testing was performed.Nine x-ray images were reviewed.The x-ray images demonstrate the balloon in different states of inflation with the final five indicating a leak of contrast.This appears to be a slow leak rather than a complete disruption of the balloon.Therefore, the investigation is confirmed for the reported balloon rupture as a pinhole rupture was noted on the balloon during inflation.Additionally, the investigation is confirmed for the identified improper procedure as an expired product was used, and the procedure was performed in a veterinary case.Per the information in the product instructions for use, the devices are to be used prior to the printed "use by" date and the indications for use do not specify veterinary cases.The user however understood the product was being used past the date and for the veterinary case both against the instructions included in the instructions for use.The root cause of the use of device past expiration date and use in veterinary case was determined to be user error.It is possible the incorrect use of the device contributed to the reported balloon rupture.However, the definitive cause of the reported balloon rupture cannot be determined based on the available 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.Per the reported information, the device was past its expiration date.This is outside of the indications for use per atlas gold instructions for use under the section "directions for use": "rotate inventory so that the catheters and other dated products are used prior to the ¿use by¿ date".Additionally, the device was used in a veterinary case.Veterinary use is not included in the indications for use per atlas gold instructions for use.Therefore, a use related issue can be confirmed.However, as the user was aware the product was expired and knowingly used the product in a veterinary case, a user letter will not be sent.H10: d4 (expiration date: 10/2022), g3, h6 (device).H11: section a through f ¿ the information provided 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
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 17974223
• MDR Text Key: 326122192
• Report Number: 2020394-2023-00908
• Device Sequence Number: 1
• Product Code: DQY
• 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
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ATG120244
• Device Lot Number: 93XD0085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• 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 Outcome(s): Life Threatening
• Patient Age: 6 MO
• Patient Sex: Female
• Patient Weight: 21 KG