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

Catalog Number CRUO14SA

Device Problems Material Puncture/Hole (1504); Material Perforation (2205); Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.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 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 upon loading the catheter onto the guide wire, the wire poked through the distal end about an inch from the tip.Another recanalization catheter was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.The lot met all release criteria.Visual/microscopic inspection:the sample was returned used.The distal end of the catheter was bunched and twisted in appearance.The catheter was still fully attached to the distal tip with no material separation noted.The sonic connector was not seated inside the nest inside the knob assembly.It is possible that the position of the sonic connector not seating inside the nest was caused by the user not properly disconnecting the crosser from the transducer.No other anomalies were noted along the length of the catheter.Functional/performance evaluation:the patency of the guidewire lumen was tested with an in-house guidewire.The guidewire was loaded through the hub but was unable to be loaded through the distal end of the catheter.A puncture in the outer catheter was noted.The outer catheter was then removed at the location of the outer catheter perforation and the guidewire lumen was found to be twisted and perforated.The perforation was likely due to the twisted guidewire lumen.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 twisting, as the guidewire lumen was observed to be twisted, resulting in the reported guidewire issues and the puncture in the 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 near the distal tip.Labeling review:the current ifu (instructions for use) states: warnings and precautions:- prior to use, the packaging and product should be inspected for signs of damage.Never use damaged product or product from a damaged package.Set up:- back the rigid portion of the catheter out of the end of the hoop, then carefully unsnap the catheter from the hoop with a gentle twisting motion.- attach the irrigation system to the irrigation lumen on the proximal end of the crosser catheter.- 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.Interventional use:- load the crosser catheter 14p, 14s, or 18 over the wire and introduce through rhv.Take care not to damage the tip of the crosser catheter during introduction; no resistance should be encountered during this process.- warning! use extra caution when loading the crosser catheter 18 over a.014¿ or a ¿docking¿ wire, as the significant mismatch in diameters may increase the likelihood of guidewire lumen piercing.

• Brand Name: CROSSER CATHETER 14S OTW
• 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: 5192997
• MDR Text Key: 30349398
• Report Number: 2020394-2015-01781
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: CRUO14SA
• Device Lot Number: GFYJ3055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2015
• 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
• Patient Age: 90 YR