MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	CQF7598
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
Date of Event	11/14/2018
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 return of the device is pending.The investigation of the reported event is currently underway.(expiry date: 06/2021).
Event or Problem Description
It was reported that during an angioplasty procedure in the cephalic vein, the pta balloon allegedly had difficulty deflating.A needle stick was used to deflate the balloon through the skin.The procedure was completed upon removal of the device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the cephalic vein, the pta balloon allegedly had difficulty deflating.A needle stick was used to deflate the balloon through the skin.The procedure was completed upon removal of the device.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the device was returned for evaluation.The device was prepped per the instructions for use, and inflated with a 10ml syringe.The device was then deflated within the specified time constraints, without any issues.Therefore, the investigation is unconfirmed for the reported deflation issue.The definitive root cause for the reported deflation issue could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Per the reported event details, the user alleged that a needle was inserted through the skin to deflate the balloon.It should be noted that the returned balloon did not exhibit any needle punctures.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 cephalic vein, the pta balloon allegedly had difficulty deflating.A needle stick was used to deflate the balloon through the skin.The procedure was completed upon removal of the device.There was no reported patient injury.
Additional Manufacturer Narrative
The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.This supplemental emdr will be submitted to report the change in lot number, based on information received on 1/31/2019.

• Brand Name: CONQUEST 40 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: 8151391
• Report Number: 2020394-2018-02186
• Device Sequence Number: 252415
• Product Code: LIT
• UDI-Device Identifier: 00801741060618
• UDI-Public: (01)00801741060618
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• 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,Followup
• Report Date (Section B): 04/17/2019

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
• Operator of Device: Health Professional
• Device Model Number: CQF7598
• Device Catalogue Number: CQF7584
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 01/31/2019; 04/12/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 02/14/2019; 04/17/2019
• 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: Required Intervention
• Patient Age: 47 YR