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

Catalog Number CQF5064

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

No medical records or images have been made available to the manufacturer.The lot number for the device has been provided.A review of the device history records is currently being performed.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 Description

It was reported that the hub of the pta balloon dilatation catheter was allegedly detached from the catheter upon opening the package in the sterile field rendering it unusable.Reportedly, another pta balloon dilatation catheter was used to complete the procedure.There was no reported patient involvement.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records were reviewed.The 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 for this lot number and issue to date.Visual inspection: the returned sample appeared to be clean.The balloon was in its original folded configuration with the stylet and balloon guard in place on the balloon.The guidewire hub was returned detached from the catheter.The guidewire hub was examined under microscopic magnification and it appeared that there was an insufficient amount of glue present at the glue fillet bond between the catheter and the guidewire hub.The proximal end of the catheter was examined under microscopic magnification and trace amounts of glue were present on the catheter at the location where it was bonded to the guidewire hub.Based on the amount of glue present on the catheter and the guidewire hub at the glue fillet bond, it appears that an insufficient amount of glue was applied.The glue fillet bond between the catheter and the inflation hub was intact and appeared to be a complete glue fillet.Functional/performance evaluation: no functional testing could be performed due to the condition of the returned sample (i.E.Hub detachment).Medical records & image/photo review: no medical records or images/photos were provided for review.Conclusion: the investigation is confirmed for a detached guidewire hub due to an insufficient amount of glue applied at the hub bond.The investigation is confirmed for a loss of bond between the catheter and guidewire hub.The root cause is manufacturing related as there was an insufficient amount of glue applied at the catheter to guidewire hub bond.This is the only complaint received for this issue to date, therefore, the complaint is an isolated event.Bard reynosa operator awareness training was performed regarding this complaint.Labeling review: specific warnings, precautions and directions for use of the dorado pta dilatation catheter are included in the current instructions for use (ifu).(b)(4).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.

• Brand Name: CONQUEST 40 PTA BALLOON DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5131885
• MDR Text Key: 28071690
• Report Number: 2020394-2015-01674
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: CQF5064
• Device Lot Number: REZF0361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1