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

Catalog Number CQF7588

Device Problems Break (1069); Leak/Splash (1354); Material Rupture (1546); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure of the basilic swing segment stenosis left upper arm, the tip of the pta balloon catheter allegedly broke.There was no reported patient injury.

Manufacturer Narrative

H10: 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.H10: d4 (expiry date: 04/2026).H11: section a through f ¿ the information provide by bd represents all 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 of the basilic swing segment stenosis via the left upper arm, the tip of the pta balloon catheter allegedly broke.It was further reported that contrast leakage was allegedly appeared to be noted on the end of the balloon close to the tip.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one conquest 40 pta dilatation catheter was returned for evaluation.During visual observations fiber disturbance was noted in the balloon.No other anomalies were noted.In the functional testing, negative pressure was applied with an in-house presto inflation device and water leak could be observed in balloon near to the distal tip.Balloon fibers stripped and under microscopic evaluation balloon longitudinal rupture could be noted near to the distal tip.No further testing was performed.No significant evidence of the break was noted during the sample analysis.Upon visual evaluation, fiber disturbance was noted throughout the balloon and no other anomalies were noted, hence the investigation was confirmed for the identified fiber disturbance and the investigation was unconfirmed for the reported break.During functional testing, the device leaked upon inflation, hence the reported balloon leak was confirmed.Further under microscopic evaluation balloon longitudinal rupture could be noted near to the distal tip.Hence, the investigation is confirmed for the reported balloon rupture.The identified balloon rupture might lead to the reported leak.However, the definitive root cause for the reported balloon leak, break and identified fiber disturbance, balloon rupture issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiration date: 04/2026), g3, h6 (device, method).H11: section a through f ¿ the information provided by bd represents all 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.

• Brand Name: CONQUEST 40
• 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. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18168275
• MDR Text Key: 328482841
• Report Number: 2020394-2023-01074
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CQF7588
• Device Lot Number: REHS0912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: Black Or African American