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

Model Number	AT75126
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical records were provided and reviewed.No medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: following successful inferior vena cava (ivc) filter retrieval, attention was turned to the occluded left iliofemoral system.A laser ablation catheter was inserted and used to successfully perform laser thrombectomy through the occluded left iliofemoral venous system.A 12mm x 6cm balloon was used to perform venoplasty along the left iliofemoral system.Post venoplasty venogram was performed as the sheath was retracted.Repeat balloon venoplasty was performed in an area of persistent narrowing n the external iliac vein at the junction of existing non-overlapping stents.At this time, the balloon would not deflate.A 21 gauge needle was inserted under fluoroscopy to access the balloon which resulted in good decompression.The balloon was easily removed.Two stents were deployed with additional angioplasty to complete the procedure.The sheaths were removed and hemostasis was achieved with manual compression.The patient was hospitalized overnight for observation.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
Medical records received and reviewed.During a recanalization procedure, after multiple inflations in the external iliac vein, a pta balloon was unable to be deflated.A needle was inserted into the balloon under fluoroscopy which resulted in good decompression, and the device was easily removed.Two stents were placed and additional venoplasty was performed to complete the procedure.The patient was hospitalized overnight for observation.
Event or Problem Description
Medical records received and reviewed.During a recanalization procedure, after multiple inflations in the external iliac vein, a pta balloon was unable to be deflated.A needle was inserted into the balloon under fluoroscopy which resulted in good decompression, and the device was easily removed.Two stents were placed and additional venoplasty was performed to complete the procedure.The patient was hospitalized overnight for observation.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review could not be performed as the lot number was not provided.Medical records review: following successful inferior vena cava (ivc) filter retrieval, attention was turned to the occluded left iliofemoral system.A laser ablation catheter was inserted and used to successfully perform laser thrombectomy through the occluded left iliofemoral venous system.A 12mm x 6cm balloon was used to perform venoplasty along the left iliofemoral system.Post venoplasty venogram was performed as the sheath was retracted.Repeat balloon venoplasty was performed in an area of persistent narrowing n the external iliac vein at the junction of existing non-overlapping stents.At this time, the balloon would not deflate.A 21 gauge needle was inserted under fluoroscopy to access the balloon which resulted in good decompression.The balloon was easily removed.Two stents were deployed with additional angioplasty to complete the procedure.The sheaths were removed and hemostasis was achieved with manual compression.The patient was hospitalized overnight for observation.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.A 12mm x 6cm atlas balloon was advanced over the wire and venoplasty was performed along the left iliofemoral system.Balloon venoplasty was performed in an area of persistent narrowing in the ely, at the junction of existing non-overlapping stents.At this time, the angioplasty balloon would not deflate.Therefore, based on the medical records, the investigation can be confirmed for failure to deflate.The definitive root cause for the deflation issue could not be determined based upon 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.

• Brand Name: ATLAS PTA BALLOON 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: 7509350
• Report Number: 2020394-2018-00659
• Device Sequence Number: 11076295
• Product Code: LIT
• UDI-Device Identifier: 00801741062414
• UDI-Public: (01)00801741062414
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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 Model Number: AT75126
• Device Catalogue Number: AT75126
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 82