MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER 14S CTO RX CATHETER; RECANALIZATION CATHETER

Catalog Number CRE14S

Device Problems Thermal Decomposition of Device (1071); Kinked (1339); Overheating of Device (1437); Material Separation (1562); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation 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 a recanalization catheter became hot to the touch during use in the popliteal artery.The health care provider reported that the recanalization catheter was removed.The hcp further reported that there was kinking to the distal tip of the catheter and a burn-like mark was reportedly found on the shaft of the catheter.There was no reported impact or consequence to the patient.

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number is reportedly unknown.Visual/microscopic inspection: the sample was returned used.The catheter was noted to be severely twisted throughout its length.The distal tip was examined under microscopic magnification and the outer catheter was noted to be partially separated from the distal tip.No other anomalies were observed to the device.Performance/functional evaluation: functional testing for overheating of the catheter could not be performed due to the poor sample condition (i.E.Twisted catheter would prevent saline from flowing to tip and would lead to overheating).Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is confirmed for material separation, as the outer catheter was partially pulled away from the distal tip.The investigation is confirmed for material twisting as the catheter was observed to be twisted.The investigation is inconclusive for the device overheating, as functional testing could not be performed due to the poor sample condition (i.E.Twisted catheter).The definitive root cause could not be determined based upon the available information.It is unknown if procedural issues during the attachment of the catheter to the transducer contributed to the twisted catheter and outer catheter separation from the distal tip.It is possible that the twisted catheter contributed to the reported overheating of the catheter.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.- for the crosser catheters 14p, 14s, and 18 only, flush the guidewire lumen of the crosser catheter using a standard 10ml syringe with heparinized saline.- do not activate the crosser recanalization system without proper irrigation.Make sure to establish proper irrigation prior to introduction into guide catheter.Always use refrigerated saline.- when manipulating the crosser catheter, the catheter shaft may become warm to the touch.A warm feeling is normal, however, if the catheter shaft becomes hot discontinue use immediately and withdraw from patient.Once removed from the patient confirm that irrigation is flowing.Additionally, set up and interventional use instructions are also included in the ifu.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.

• Brand Name: CROSSER 14S CTO RX CATHETER
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5020252
• MDR Text Key: 23937523
• Report Number: 2020394-2015-01353
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRE14S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2015
• 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 Number: 1