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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. CONQUEST 40; PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number CQF7586
Device Problems Deflation Problem (1149); Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/17/2023
Event Type  malfunction  
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos and a video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2025).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.H3 other text : device pending return.
 
Event Description
It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the balloon allegedly got stuck inside the vessel and was not easily removed through the sheath.Reportedly, the balloon was forced out through the sheath while being inflated and removed.There was no reported patient injury.
 
Event Description
It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the balloon allegedly got stuck inside the vessel and was not easily removed through the sheath.Reportedly, the balloon was forced out through the sheath while being inflated and removed.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 loaded into an unknown sheath was returned for evaluation.The catheter shaft is noted to be stretched and bunched.The balloon was also noted to be bunched.No other anomalies were noted during the visual evaluation.No functional testing was performed due to the condition of the device.Also, three photos were reviewed.The first and second photo shows the balloon inside a plastic package.The balloon was noted to be bloody and to be in a deflated and unevenly folded condition.The catheter shaft and introducer sheath were severely bunched, and the catheter was still loaded within the introducer sheath.The third photo shows the label of the device, on which all the product details can be verified.No other anomalies were noted.Also, the video was reviewed.From the submitted video, the catheter was seen loaded within the introducer sheath, and the catheter shaft was severely bunched.No other specific anomalies were noted.Therefore, the returned sample analysis of the original device and based on the submitted photos and video, it was confirmed that the catheter was loaded within the introducer sheath and that the shaft was severely bunched.Therefore, the investigation is confirmed for the reported sheath removal difficulty and the identified catheter shaft bunching; however, the investigation remains inconclusive for the reported deflation issue and balloon entrapment within the vessel, as no objective evidence could be noted based on the submitted photos and videos.A definitive root cause for the reported sheath removal difficulty, deflation issue ,balloon entrapment within the vessel and the identified catheter shaft bunching 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: d4 (expiry date: 08/2025), g3 ,h6 (device).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.
 
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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 Key17486673
MDR Text Key320762360
Report Number2020394-2023-00574
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741060564
UDI-Public(01)00801741060564
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
K120660
Number of Events Reported1
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 10/21/2023
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
Device Operator Health Professional
Device Catalogue NumberCQF7586
Device Lot NumberREGW2699
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/17/2023
Initial Date FDA Received08/09/2023
Supplement Dates Manufacturer Received10/19/2023
Supplement Dates FDA Received10/23/2023
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 Number1
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