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

Catalog Number	CQF7588
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Material Rupture (1546); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
H10: our firm received an fda email correspondence on 8-july-2024 from mdr data systems team, latania parker, indicating that the information (specifically the unique device identifier (udi) information in section d) of the previously submitted fda form 3500a, was incorrect and a request was made to submit supplemental report(s) with the entire udi number including the di and pi fields, all numbers, letters, parentheses, and symbols in the ¿unique device identifier (udi) #¿ fields.This supplemental report is in response to that request.H11: d2: medical device type- lit; dqy.D4: medical device expiration date- 04/30/2026.D4: udi- (b)(4).H4: device manufacture date- 05/31/2023.
Event or Problem 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 had allegedly appeared to be noted on the end of the balloon close to the tip.There was no reported patient injury.

• Brand Name: CONQUEST 40
• Common Device Name: 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
• Report Number: 2020394-2023-01074
• Device Sequence Number: 12417761
• Product Code: LIT
• UDI-Device Identifier: 00801741060571
• UDI-Public: (01)00801741060571(11)230531(17)260430(10)REHS0912
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 04/30/2026
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 02/14/2024; 07/08/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 02/24/2024; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: Black Or African American