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

Catalog Number CQ7584J

Device Problems Material Frayed (1262); Retraction Problem (1536); Material Rupture (1546); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.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 during an angioplasty procedure, the pta balloon allegedly ruptured under nominal pressure during the first inflation in a calcified radial vein.There was no reported difficulty in retracting the balloon through the introducer sheath.Reportedly, another balloon was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, (b)(4) material testing, manufacturing process, and quality control inspection.This 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 that has been reported for this corporate lot number to date.Visual inspection: the sample was returned.Two syringes were returned with the sample, one was attached to the inflation port and one was attached to the introducer sheath.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 8 mm x 4 cm balloon.Fiber disturbance was identified near the distal cone of the balloon.No other anomalies were identified to the device at this time.Functional/performance evaluation: fiber disturbance was noted to the balloon, located on the distal cone of the balloon.The balloon was stripped of its fibers.A longitudinal rupture was observed 5.3 cm from the distal tip.The longitudinal rupture was measured to be 0.3 cm in length.No further functional testing could be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned.The investigation was confirmed for a longitudinal rupture on the barrel of the balloon.The investigation was confirmed for material frayed, as fiber disturbance was found on the distal cone of the balloon.Per the reported complaint details, the lesion was calcific.Therefore it is possible that patient factors contributed to the event.However, the definitive root cause is unknown.Labeling review: the current (b)(6) ifu (instructions for use) states: method for use: contents supplied sterile using ethylene oxide (eo).Non-pyrogenic.Do not use if sterile barrier is opened or damaged.To reduce the potential for vessel damage, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.[applying excessive force to the catheter can result in tip breakage or balloon separation.] do not exceed the rbp recommended for this device.To prevent over pressurization, use of inflation device with manometer is recommended.[balloon rupture may occur if the rbp rating is exceeded.] careful attention must be paid to the expansion of the stents, dilatation of calcified lesions or tortuous anatomy.[it may lead to catheter damage or balloon rupture.(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.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured under nominal pressure during the first inflation in a calcified radial vein.There was no reported difficulty in retracting the balloon through the introducer sheath.Reportedly, another balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: CONQUEST PTA BALLOON DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 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 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6214107
• MDR Text Key: 63625205
• Report Number: 2020394-2016-01214
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741127489
• UDI-Public: (01)00801741127489(17)190228(10)REAP2316
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: CQ7584J
• Device Lot Number: REAP2316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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