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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 CRU14SA
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2016
Event Type  malfunction  
Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.The device has been returned to the manufacturer for evaluation.As the lot number for the device was provided, a review of the device history records is currently being performed.The investigation of the reported event is currently underway.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 during use in the right anterior tibial artery, the guidewire allegedly became stuck in the recanalization catheter.There was no reported retraction difficulty through the sheath.Reportedly, another catheter 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 subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot meets all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual/microscopic inspection: the catheter was examined under microscopic magnification, and both the inner and outer catheter were torn and twisted around the core wire, distal to the rapid exchange junction.The outer catheter was torn at the rapid exchange junction.The inner guidewire lumen was torn and protruding out of the outer catheter.A complete break in the inner guidewire lumen was observed near the rapid exchange junction.The inner guidewire lumen and outer catheter were observed to be bunched near the distal end of the catheter.The guidewire was spiraled in appearance and was kinked in several locations.No other anomalies were noted along the length of the catheter.Functional/performance evaluation: the guidewire was unable to be removed from the catheter likely due vital fluid and bunching of the inner guidewire lumen.Further functional testing could not be performed due to the poor sample condition (i.E.Torn and broken).Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: one electronic photo was returned and reviewed.The photo shows a crosser rx catheter.The guidewire is spiraled in appearance and is kinked throughout its length.The inner guidewire lumen appears to be torn and protruding out of the outer catheter.The distal end of the guidewire is protruding out the distal tip and appears to be bent.Based upon the photo provided, device-device incompatibility and a torn catheter can be confirmed.Conclusion: the device was returned and a photo was provided.The investigation is confirmed for device-device incompatibility, based on the condition of the returned sample (i.E.Guidewire was stuck inside catheter and catheter was bunched).The investigation is confirmed for torn material, as the catheter was torn at the rapid exchange junction.The investigation is confirmed for a broken inner guidewire lumen.The definitive root cause could not be determined based upon the available information.It is unknown if the original guidewire, patient issues, and/or procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: warnings and precautions: when using the crosser in tortuous anatomy, the use of a support catheter is recommended to prevent kinking or prolapse of the crosser catheter tip.Kinking or prolapse of the tip could cause catheter breakage and/or malfunction.It is not recommended to use the crosser over wires which have polymer-jacketed distal ends.Adverse events: as with most percutaneous interventions, potential adverse effects include: bleeding which may require transfusion or surgical intervention, hematoma, perforation, dissection, guidewire entrapment and/or fracture, hypertension/hypotension, infection or fever, allergic reaction, pseudoaneurysm or fistula aneurysm, acute reclosure, thrombosis, ischemic events, distal embolization, excessive contrast load resulting in renal insufficiency or failure, excessive exposure to radiation, stroke/cva, restenosis, repeat catheterization / angioplasty, peripheral artery bypass, amputation, death or other bleeding complications at access site.Interventional use: advance the guidewire and crosser catheter 14p, 14s, or 18 to the lesion site.Withdraw the guidewire approximately 1cm within the catheter so that the tip of the crosser catheter is the leading edge.Slowly advance the catheter tip through the lesion.Apply steady, constant pressure so the tip of the catheter is engaged to the lesion.Upon successful recanalization of the lesion, advance the guidewire distal to the lesion and then withdraw the crosser 14p, 14s, or 18 catheter.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 during use in the right anterior tibial artery, the guidewire allegedly became stuck in the recanalization catheter.There was no reported retraction difficulty through the sheath.Reportedly, another catheter 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
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5760665
MDR Text Key49236994
Report Number2020394-2016-00592
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072776
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2018
Device Catalogue NumberCRU14SA
Device Lot NumberGFAP2125
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age79 YR
Patient Weight91
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