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

Catalog Number CQ7594J

Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The catalog number identified in section d4 has not been cleared in the us, but is similar to the conquest pta dilatation balloon products that are cleared in the us.The 510 k number and pro code for the conquest pta dilatation balloon products are identified.Accordingly, this event has been determined to be mdr reportable.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.Another device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in the brachial vein, the pta balloon allegedly ruptured.Another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

This supplemental emdr is being submitted to report the change in reportability, based on information received on 1/17/2019.This file originally reported a malfunction mdr.After assessing the information received on 1/17/2019, this file is no longer mdr reportable.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The catalog number identified in section d4 has not been cleared in the us, but is similar to the conquest pta dilatation balloon products that are cleared in the us.The 510 k number and pro code for the conquest pta dilatation balloon products are identified in d2 and g5.Accordingly, this event has been determined to be mdr reportable.(expiry date: 12/2019).H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that during an angioplasty procedure in the brachial vein, the pta balloon allegedly ruptured.Another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device and one image were returned for evaluation.A visual inspection found the device stuck in the user's introducer sheath.Additionally, a peeled outer layer and frayed fibers were noted on the balloon.The outer layer and fibers were pushed distally on the proximal cone, and the distal end of the user's sheath was noted to be slightly damaged.Therefore, the investigation is confirmed for a peeled outer layer, frayed fibers, and sheath-related retraction issues.The image showed the device inflated in the patient's arm.Based on the image review, the device appeared inflated and no rupture could be confirmed.However, the device was inflated and a longitudinal rupture was noted on the proximal cone, at the location of the frayed fibers.Therefore, the investigation is confirmed for a longitudinal rupture.It is likely that the balloon rupture led to the retraction issues through the sheath, and possibly the frayed fibers on the proximal cone at the location of the rupture.However, the definitive root cause for the rupture or frayed fibers could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the conquest pta dilatation balloon products that are cleared in the us.The 510 k number and pro code for the conquest pta dilatation balloon products are identified in d2 and g5.Accordingly, this event has been determined to be mdr reportable.H10: d4 (expiry date: 12/2019).H11: h3, h6 (trending device code: 1536 - retraction problem).

• Brand Name: CONQUEST PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8250291
• MDR Text Key: 133202322
• Report Number: 2020394-2018-02321
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741127526
• UDI-Public: (01)00801741127526
• Combination Product (y/n): N
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CQ7594J
• Device Lot Number: REAZ1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1