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

Catalog Number CQ75124

Device Problems Deflation Problem (1149); Inflation Problem (1310); Product Quality Problem (1506); Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2014

Event Type  Injury  

Event Description

It was reported that the pta balloon would not inflate at the distal end during the first inflation at 15 atm in the subclavian vein.The inflated balloon was retracted to the sheath and a needle was inserted through the skin to deflate the balloon.The balloon catheter was difficult to remove through the sheath; therefore, the catheter and sheath were removed as a single unit.There was no reported patient injury.

Manufacturer Narrative

The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.The device was returned.The investigation is inconclusive for inflation and deflation issues, as the balloon was unable to be functionally tested due to the poor sample condition (i.E.Detached balloon).The investigation is confirmed for a product quality issue , as the glue bullet was found to be improperly formed and lodged within the outer catheter shaft.The investigation is also confirmed for retraction problems and a detached balloon, as the balloon was detached and unable to removed from the sheath.The evaluation found the glue bullet was lodged within the catheter shaft, partially blocking the inflation/deflation ports.Additionally, the glue bullet did not appear perpendicular to the polymide surface, which may have contributed to it becoming lodged.The root cause for the inflation and deflation issues is related to the glue bullet becoming lodged within the catheter shaft, which led to the retraction issues and the balloon detachment.The root cause for the improperly formed glue bullet is manufacturing related.Operator awareness training regarding the glue bullet process was performed.

Manufacturer Narrative

A medical intervention was required to deflate the pta balloon with a needle stick through the skin.There was no known impact or consequence to patient.After further clinical review of this event with bard's medical department, this event was reassessed and determined to be mdr reportable as a serious injury pursuant to 21 cfr part 803.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The facility was able to provide new patient information, which was updated in the appropriate sections.Medical records received and reviewed.Based on medical records, the patient had an angioplasty procedure performed for stenosis at the subclavian vein/innominate junction.A seldinger technique was used to gain access into the cephalic vein.A pta and blessed balloon was advanced to the lesion site and inflated (pressure rate and time of inflation was not provided); however, the healthcare provider was unable to deflate the pta balloon.The pta balloon was slowly retrieved over the guide wire to the location of the introducer sheath; the pta balloon could not be removed through the introducer sheath.Lidocaine was administered at the location of the pta balloon and a 25gauge needle was advanced through the skin to deflate the pta balloon at the site of the introducer sheath.The pta balloon and the introducer sheath were removed as one unit without incident.Two additional pta balloons (different sizes) were used to complete the angioplasty of the stenosis subclavian vein successfully.The subclavian vein was reported to be patent with good blood flow.The patient was reported to be hemodynamically stable and in good condition at the conclusion of the procedure.

Manufacturer Narrative

A voluntary recall was initiated on 3/23/2015 bard peripheral vascular has confirmed that the product code and lot number identified in this event may be at risk of having deflation related issues.In the event a pta balloon will not deflate, immediate intervention is required in order to deflate the balloon and allow for continued blood flow in many cases, this can be accomplished percutaneously by inserting a device to the pta balloon and puncturing the balloon and/or a sheath, allowing its withdrawal.

• Brand Name: CONQUEST 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: 4210337
• MDR Text Key: 4981730
• Report Number: 2020394-2014-00359
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/15/2014

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: 03/31/2017
• Device Catalogue Number: CQ75124
• Device Lot Number: REYC1426
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 08/08/2014
• Supplement Dates Manufacturer Received: 02/09/2015; 09/30/2015; 09/30/2015
• Supplement Dates FDA Received: 03/06/2015; 03/30/2015; 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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: 43 YR
• Patient Weight: 68