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

Model Number ATG80126

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Failure to Advance (2524); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

Event Type  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.The investigation of the reported event is currently underway.Expiration date: 09/2024.

Event Description

It was reported that during an angioplasty procedure, balloon allegedly got stuck in the patient.It was further reported that the proximal side of the balloon was connected but the portion from the back had disconnected from the catheter and seemed to be mushroomed.Furthermore, since the balloon was attached to the fistula, the catheter was cut to pull it through.Reportedly the catheter was still on the wire and detached segment was removed using snare.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, balloon allegedly got stuck in the patient.It was further reported that balloon allegedly disconnected from the catheter and since it was attached to the fistula the catheter was cut to pull it thru.It was further reported that the balloon was ruptured and catheter was still on the wire.Reportedly, detached segment was removed using snare and femoral access was gained to pull the balloon and catheter.The current status of the patient was unknown.

Manufacturer Narrative

H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.H10: 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.H10: d4 (expiry date: 09/2024), g3.H11: b5, h1, h6 (patient, 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.

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 detached in three segments was received for evaluation.Segment one consisted of the y-body and strain relief connected to a 3-way stop cock.Segment two consisted of the outer catheter with a complete circumferential break.Segment three consisted of the inner guidewire lumen still attached to the balloon with the proximal end frayed.No functional testing was performed due to the condition of the sample.Therefore, the investigation is confirmed for the reported detachment as the balloon was returned detached in three segments.However, the investigation is inconclusive for the reported balloon rupture and deflation problem as no functional testing could be performed due to the condition of the sample.The investigation is also inconclusive for the reported removal difficulty as the conditions for use could not be replicated in the laboratory.A definitive root cause for the alleged balloon rupture, detachment, removal difficulty and deflation problem 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: 09/2024).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 Description

It was reported that during an angioplasty procedure, balloon allegedly got stuck in the patient.It was further reported that balloon allegedly disconnected from the catheter.Since it was attached to the fistula the catheter was cut to pull it thru.Reportedly the balloon was ruptured and catheter was still on the wire.Detached segment was removed using snare.Femoral access was gained to pull the balloon and catheter.The current status of the patient was unknown.

• 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: 16601912
• MDR Text Key: 312049239
• Report Number: 2020394-2023-00187
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060717
• UDI-Public: (01)00801741060717
• 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: 04/18/2023

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
• Device Operator: Health Professional
• Device Model Number: ATG80126
• Device Catalogue Number: ATG80126
• Device Lot Number: 93WF0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 03/17/2023; 04/18/2023
• Supplement Dates FDA Received: 04/14/2023; 04/24/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 68 KG