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

Model Number U415044RX

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/09/2020

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 05/2022).

Event Description

It was reported that during an angioplasty procedure in the superficial femoral artery, the catheter shaft of the pta balloon allegedly detached and remained in the patient¿s body.It was further reported that medical intervention was required to remove the detached segment.Patient¿s status is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was conducted and there was nothing to indicate that there was a manufacturing related cause for this event.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.Investigation summary: the device was returned for evaluation.A visual inspection was performed and the device was found in two segment.In first segment consist of the inflation hub and partial catheter.Segment two consist of remaining catheter and the balloon.No other anomalies were noted to the device.Performance evaluation was not performed due to the condition of the device.Therefore, the investigation is confirmed for the reported detachment of device or device component, as the device was returned in two segments, with a portion of the balloon and catheter shaft detached from the rest of the device.The definitive root cause for the reported detachment of device or device component could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.H10: d4 (expiry date 05/2022).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 in the superficial femoral artery, the catheter shaft of the pta balloon allegedly detached and remained in the patient¿s body.It was further reported that medical intervention was required to remove the detached segment.Patient¿s status is unknown.

• Brand Name: ULTRAVERSE RX 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: 10030926
• MDR Text Key: 190111406
• Report Number: 2020394-2020-03372
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741057465
• UDI-Public: (01)00801741057465
• Combination Product (y/n): N
• PMA/PMN Number: K131199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U415044RX
• Device Catalogue Number: U415044RX
• Device Lot Number: CMDT0455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70