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

Model Number ATG80144

Device Problems Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.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 a venous angioplasty and stenting procedure the pta balloon allegedly ruptured at 6atm and subsequently got stuck inside the patient.It was further reported that a second access site was created to remove the balloon successfully.Upon inspection, the balloon was allegedly detached from the proximal end of the catheter shaft but still attached distally.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation in the user's introducer sheath.A visual inspection found a complete break at the proximal balloon weld joint.The inner guidewire lumen was noted to be stretched, and the balloon material was noted to be prolapsed over the distal tip.Therefore, the investigation is confirmed for a break of the proximal balloon weld.The investigation is unconfirmed for the reported detachment; it is likely the user perceived the break as a detachment.Additionally, based on the stretching to the inner lumen and the condition to the balloon, the investigation is confirmed for retraction issues.The investigation is inconclusive for the reported rupture as the device was unable to be functionally tested.The investigation is confirmed for a dislodged proximal marker band.The marker bands likely dislodged as the inner lumen stretched and as the proximal balloon weld broke distally.It is likely that the balloon weld break resulted in the retraction issues through the sheath.However, the definitive root cause for the identified weld break or reported balloon rupture could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiration date:09/2021), (device code: 1069- break).

Event Description

It was reported that during a venous angioplasty and stenting procedure the pta balloon allegedly ruptured at 6atm and subsequently got stuck inside the patient.It was further reported that a second access site was created to remove the balloon successfully.Upon inspection, the balloon was allegedly detached from the proximal end of the catheter shaft but still attached distally.There was no reported patient injury.

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8229275
• MDR Text Key: 132485094
• Report Number: 2020394-2018-02300
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755
• Combination Product (y/n): N
• PMA/PMN Number: K181323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

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: ATG80144
• Device Catalogue Number: ATG80144
• Device Lot Number: 93WC0118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention