MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	CQF7544
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.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.(expiry date - 12/2018).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 or Problem Description
It was reported during an angioplasty procedure of a left upper arm fistula, the pta balloon allegedly ruptured at 15 atm.The balloon was removed in its entirety through the sheath without difficulty.There was no reported detachment of balloon material nor any vessel damage.The procedure was completed with another balloon.There was no reported patient injury.
Event or Problem Description
It was reported during an angioplasty procedure of a left upper arm fistula, the pta balloon allegedly ruptured at 15 atm.The balloon was removed in its entirety through the sheath without difficulty.There was no reported detachment of balloon material nor any vessel damage.The procedure was completed with another balloon.There was no reported patient injury.
Additional 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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was received for evaluation.The device was inflated and water was seen exiting the proximal cone of the balloon.The fibers were stripped and a partial circumferential rupture was noted on the balloon.Therefore, the investigation is confirmed for a circumferential rupture.The definitive root cause for the identified circumferential rupture could not be determined based upon 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: d4 (expiry date - 12/2018).

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7779427
• Report Number: 2020394-2018-01445
• Device Sequence Number: 1560392
• Product Code: LIT
• UDI-Device Identifier: 00801741060342
• UDI-Public: (01)00801741060342
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CQF7544
• Device Catalogue Number: CQF7544
• Device Lot Number: REZL2140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 86