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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 Material Separation (1562); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
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 510k number for the crosser cto recanalization catheters products is identified.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.Expiry date (08/2022).
 
Event Description
It was reported that during a recanalization procedure, the marker allegedly misaligned.It was further reported that the marker was found detached after removal.Another device was used to complete the procedure.There was no reported patient injury.
 
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 14s crosser cto recanalization catheter returned for sample evaluation.During visual inspection the device appeared to be clean.No anomalies were noted to saline hub, or distal tip.However, slight twisting of the inner core wire was noted which caused the outer catheter to have slight twisting as well.Marker band is present and undamaged.Upon microscopic examination slight material separation was noted just below the distal tip.Functional testing was not performed due to the condition of the device.Therefore, the investigation is confirmed for the alleged material separation as the tip had a material separation under magnification.The investigation is also confirmed for the identified material twisting, as the slight twisting was noted on the outer catheter.However, the investigation is unconfirmed for the reported marker band detachment.A definitive root cause for the alleged, detachment of device or device component, material separation and identified material twisting 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 510k number for the crosser cto recanalization catheters products is identified in d2 and g4.H10: d4 (expiry date: 08/2022), g3 h11: h6 (result and conclusion) 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.H3 other text : see h10.
 
Event Description
It was reported that during a recanalization procedure, the marker allegedly misaligned.It was further reported that the marker was found detached after removal.Another device 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 Key11092804
MDR Text Key224296372
Report Number2020394-2020-20972
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
Report Date 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCRE14S
Device Lot NumberGFEV1294
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Date Manufacturer Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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