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

Catalog Number CQ75124

Device Problems Break (1069); Deflation Problem (1149); Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/28/2015

Event Type  Injury  

Event Description

It was reported that the pta balloon would not deflate after the first inflation (atm unknown) in the subclavian vein.A needle stick through the skin was used to deflate the balloon.There was no reported retraction difficulty through the sheath.Another balloon was used to complete the procedure.There was no known impact or consequence to the patient.

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation 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.

Manufacturer Narrative

The lot number was provided and the lot device history records were reviewed.There was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.Visual inspection: the sample was returned.The distal end of the balloon was partially prolapsed over the distal tip and was protruding out the distal end of the introducer sheath.The proximal end of the balloon bond was protruding out the proximal hub of the introducer sheath.A complete circumferential outer catheter break was noted at the proximal balloon glue joint.Stretching of the outer catheter was noted just proximal to the break.The glue bullet was located just proximal to the proximal balloon glue joint and was still present on the polyimide.This will be considered an incidental finding, as the break at the proximal balloon glue joint combined with excessive force may have contributed to the balloon becoming lodged inside the catheter shaft.It is unknown whether the glue bullet was lodged within the shaft during the deflation attempts.The outer diameter of the glue bullet could not be measured, as it was loose on the polyimide.The distal end of the sheath was examined and found the edge of the sheath tip was severely flared out, indicating retraction issues.The proximal end of the sheath was severely bunched, indicating retraction issues.Functional/performance evaluation: an attempt was made to retract the catheter through the sheath, but was unsuccessful.The balloon was able to be advanced through the sheath with resistance.Upon removal, it was noted that there was no fiber disturbance present on the balloon.Medical records & image/photo review: no medical records or images/photos were provided; therefore, a review could not be performed.Conclusion: the investigation is inconclusive for deflation issues, as the balloon was unable to be functionally tested due to the condition of the returned sample (i.E.Break at balloon glue joint).The investigation is confirmed for retraction problems and a break, as the balloon was unable to be removed from the sheath and an outer catheter break was present at the proximal balloon glue joint.The root cause for the deflation issues is unknown.Labeling review: specific warnings, precautions and directions for use of the conquest pta dilatation catheter are included in the current instructions for use (ifu).

• Brand Name: CONQUEST PTA BALLOON DILATATIN 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: 4874983
• MDR Text Key: 17541954
• Report Number: 2020394-2015-00966
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,hea
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: CQ75124
• Device Lot Number: REYJ0852
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 64