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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETERS
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BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETERS Back to Search Results
Catalog Number CRE14S
Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the crosser cto recanalization catheters products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheters products are identified.(expiry date: 01/2022).Device pending return.
 
Event Description
It was reported that during a recanalization procedure, the core wire in the catheter was allegedly found broken.It was further reported that the tip of catheter which was remained in the patient's body was removed using snare.Patient current status was unknown.
 
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.Investigation summary: one crosser 14s cto recanalization catheter was returned for review.Visual evaluation of the crosser revealed a corewire was detached from catheter.No functional testing was performed due to the condition of the sample, therefore, the investigation is confirmed for detachment of device or device component.A definitive root cause for the detachment of device or device component could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the crosser cto recanalization catheters products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheters products are identified in d2 and g4.H10: d4 (expiry date: 01/2022).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.
 
Event Description
It was reported that during a recanalization procedure, the core wire in the catheter was allegedly found broken.It was further reported that the tip of catheter which was remained in the patient's body was removed using snare.There was no reported patient injury.
 
Manufacturer Narrative
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.The catalog number identified has not been cleared in the us but is similar to the crosser cto recanalization catheters products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheters products are identified.(expiry date: 01/2022), (patient, device, method) 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.
 
Event Description
It was reported that during a recanalization procedure, the core wire in the catheter was allegedly found broken.It was further reported that the tip of catheter which was remained in the patient's body was removed using snare.There was no reported patient injury.
 
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Brand Name
CROSSER CTO RECANALIZATION CATHETERS
Type of Device
RECANALIZATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key11053127
MDR Text Key223141247
Report Number2020394-2020-20899
Device Sequence Number1
Product Code PDU
Combination Product (y/n)N
PMA/PMN Number
K161208
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCRE14S
Device Lot NumberGFDY3035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/22/2020
Supplement Dates Manufacturer Received05/01/2021
05/28/2021
Supplement Dates FDA Received05/27/2021
06/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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