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

Model Number	CQ75124
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number of the device was provided.The device history records are currently under review.The review of the images and photos provided are pending.The investigation is currently underway.(expiry date: 06/2022).
Event or Problem Description
It was reported that during an angioplasty procedure via jugular vein, the pta balloon allegedly detached and traveled to the pulmonary artery.It was reported that the balloon was deflated and attempted to be pulled through venotomy, however, these attempts were unsuccessful due to tightness.The physician tried to inflated the balloon once again to make the venotomy bigger and remove the balloon from the patient, but during this attempt using a syringe to apply pressure, the balloon, part of the shaft and other materials detached and traveled to the pulmonary artery.The patient was sent to the hospital where interventional radiologist was able to retrieve the devices successfully with no harm to the patient.There was no reported complications to the patient, and was reported to be medically stable.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: although the device was not returned for evaluation, medical images were provided for review.From the image review, the balloon manipulation was noted to have occurred at the curvature in the distal right subclavian artery and the superior vena cava.The balloon appeared to be intact in the provide images, and no contrast was seen outside of the balloon.Three electronic photos were also provided for review.Photo 1 shows a balloon detached from the rest of the device, and caught in a snare.The balloon is bloody and appears to be either partially inverted or prolapsed.Photo 2 shows a balloon detached from the rest of the device, and caught in a snare.The balloon is bloody and appears to be either partially inverted or prolapsed.A portion of the inner lumen appears to be sticking out from the proximal balloon joint.Photo 3 shows a balloon detached from the rest of the device being held vertically.The balloon appears to be partially inverted in the photo.Based on the photo review, a balloon and inner lumen detachment can be confirmed.However, the investigation is inconclusive for the reported entrapment, as no confirmations of entrapment could be made from the provided images.The definitive root cause for the balloon detachment and reported entrapment could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the 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.
Event or Problem Description
It was reported that during an angioplasty procedure via jugular vein, the pta balloon allegedly detached and traveled to the pulmonary artery.It was reported that the balloon was deflated and attempted to be pulled through venotomy, however, these attempts were unsuccessful due to tightness.The physician tried to inflated the balloon once again to make the venotomy bigger and remove the balloon from the patient, but during this attempt using a syringe to apply pressure, the balloon, part of the shaft and other materials detached and traveled to the pulmonary artery.The patient was sent to the hospital where interventional radiologist was able to retrieve the devices successfully with no harm to the patient.There was no reported complications to the patient, and was reported to be medically stable.

• Brand Name: CONQUEST 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: 9531517
• Report Number: 2020394-2019-05876
• Device Sequence Number: 2313430
• Product Code: DQY
• UDI-Device Identifier: 00801741063251
• UDI-Public: (01)00801741063251
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: CQ75124
• Device Catalogue Number: CQ75124
• Device Lot Number: REDU3492
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 03/10/2020
• 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