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

Catalog Number	ATG120142
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during an angioplasty procedure in the iliac vein, the pta balloon allegedly got stuck inside a wall stent and subsequently ruptured circumferentially during the first inflation (atm unknown).It was further reported that upon retraction through the 8fr sheath, the balloon material detached and turned inside out.Reportedly, the heath care provider (hcp) attempted to remove the balloon through the 8fr sheath but was unsuccessful.The hcp decided to cut the balloon and the catheter wire and place a 14fr sheath but still was not able to remove the detached balloon segment.The hcp upsized the sheath to 18fr and was able to remove the detached balloon segment successfully.The procedure was concluded and no further treatment was provided.There was no reported patient injury.
Additional 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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: a partial device segment and two images were returned for evaluation.A visual inspection found just the distal portion of the inner guidewire lumen and balloon returned.The proximal end of the balloon had broken from the proximal balloon weld and the balloon material was returned folded over the distal tip.Additionally, the proximal marker band had dislodged distally.Therefore, the investigation is confirmed for a break at the proximal balloon weld.The investigation is unconfirmed for detachment as the user likely perceived the break as a detachment.The investigation is confirmed for a dislodged marker band and for retraction issues as the balloon material was folded over the distal tip.However, the investigation is inconclusive for the reported circumferential rupture, due to the returned sample condition.Based on the condition of the returned sample, it is likely that resistance was encountered by the user leading to excessive force being applied to the device as it was being withdrawn through the sheath.This excessive force led to the balloon breaking from the shaft, and the marker band being dislodged.However, the definitive root cause for the identified retraction issues and weld break could not be identified 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.
Event or Problem Description
It was reported that during an angioplasty procedure in the iliac vein, the pta balloon allegedly got stuck inside a wall stent and subsequently ruptured circumferentially during the first inflation (atm unknown).It was further reported that upon retraction through the 8fr sheath, the balloon material detached and turned inside out.Reportedly, the heath care provider (hcp) attempted to remove the balloon through the 8fr sheath but was unsuccessful.The hcp decided to cut the balloon and the catheter wire and place a 14fr sheath but still was not able to remove the detached balloon segment.The hcp upsized the sheath to 18fr and was able to remove the detached balloon segment successfully.The procedure was concluded and no further treatment was provided.There was no reported patient injury.

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7622642
• Report Number: 2020394-2018-00930
• Device Sequence Number: 1623634
• Product Code: LIT
• UDI-Device Identifier: 00801741060748
• UDI-Public: (01)00801741060748
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K122984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2020
• Device Catalogue Number: ATG120142
• Device Lot Number: 93YB0096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 19 YR