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

Catalog Number CQ7594

Device Problems Material Frayed (1262); Material Invagination (1336); Retraction Problem (1536); Material Rupture (1546); Sticking (1597)

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

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.The device has been returned to the manufacturer for evaluation.As the lot number for the device has not been provided, a review of the device history records could not be 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 pta balloon was returned stuck inside of an introducer sheath and the distal tip of the balloon was prolapsed.There was no reported impact or consequence to the patient.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted as the investigation is lot number unknown.Visual inspection: the sample was returned used.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 9mm x 4cm balloon.The balloon was returned within an unknown 7fr introducer sheath.The distal end of the balloon was protruding from the distal end of the introducer sheath.The balloon was bunched and prolapsed over the distal tip, indicating retraction issues.The catheter was stretched near the proximal balloon glue joint.The sheath was examined under microscopic magnification and the distal end of the sheath was flared in appearance, indicating retraction issues.Functional/performance evaluation: the guidewire was unable to be removed from the catheter.The catheter was unable to be retracted through the introducer sheath.The balloon was advanced out of the sheath with resistance.Fiber disturbance was noted to the balloon, located 4.6cm from the distal tip.The balloon was stripped of its fibers.A longitudinal rupture was observed 4.5cm from the distal tip.The longitudinal rupture was measured to be 0.8cm in length.No further functional testing could be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is confirmed for sheath retraction issues due to the condition in which the sample was received (i.E.Prolapsed balloon material at distal tip).The investigation is confirmed for a longitudinal rupture on the barrel of the balloon.The investigation is confirmed for material frayed, as fiber disturbance was found on the proximal cone of the balloon.It is likely that the rupture contributed to the retraction issues.However, the definitive root cause for the rupture could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the current conquest pta dilatation catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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 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: 5336330
• MDR Text Key: 35218132
• Report Number: 2020394-2015-02077
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CQ7594
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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