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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETER Back to Search Results
Catalog Number CRE14S
Device Problems Fracture (1260); Material Separation (1562); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/27/2018
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified has not been cleared in the us, but is similar to the crosser cto recanalization catheter products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheter products are identified, respectively.No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.(expiration date: 06/2019).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 Description
It was reported that after 4 minutes and forty six seconds of activation, the distal tip of the recanalization catheter allegedly separated from the catheter.The recanalization catheter was removed without incident.Reportedly, the lesion was successfully crossed and balloon angioplasty was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.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: two segments of a crosser 14s catheter were returned for evaluation.Based on the visual inspection the investigation is confirmed for tip detachment as well as material twisted due to the twisting on the catheter.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.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.
 
Event Description
It was reported that after 4 minutes and forty six seconds of activation, the distal tip of the recanalization catheter allegedly separated from the catheter.The recanalization catheter was removed without incident.Reportedly, the lesion was successfully crossed and balloon angioplasty was used to complete the procedure.There was no reported patient injury.
 
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Brand Name
CROSSER CTO RECANALIZATION CATHETER
Type of Device
RECANALIZATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7807700
MDR Text Key117961257
Report Number2020394-2018-01535
Device Sequence Number1
Product Code PDU
UDI-Device Identifier10801741125420
UDI-Public(01)10801741125420
Combination Product (y/n)N
PMA/PMN Number
K161208
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 01/28/2019
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 NumberCRE14S
Device Lot NumberGFBS1220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2018
Initial Date Manufacturer Received 07/30/2018
Initial Date FDA Received08/22/2018
Supplement Dates Manufacturer Received01/09/2019
Supplement Dates FDA Received01/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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