MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER RECANALIZATION CATHETER

Catalog Number	CRU14SA
Medical Device Problem Codes	Material Puncture/Hole (1504); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was 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 or Problem Description
It was reported that the recanalization catheter allegedly became stuck on the guidewire during use in the right posterior tibial.The recanalization catheter and the guidewire were removed together as a single unit from the patient and access was lost at the lesion site.Reportedly, the procedure was completed with another guide wire and catheter.There was no reported patient injury.
Additional 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 met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual/microscopic inspection: the sample was returned clean.Under microscopic magnification (20x) a portion of the guidewire was found to be uncoiled and was observed to be puncturing through the catheter 1.8cm from the distal tip.No other anomalies were noted along the length of the catheter.Functional/performance evaluation: the guidewire was retracted and the proximal end of the guidewire was used to test the patency of the guidewire lumen.The proximal end of the guidewire was loaded through the rapid exchange junction and exited the distal tip with no issues.The proximal end of the guidewire was then inserted through the distal tip of the catheter and it exited the rapid exchange junction with no issues.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the sample was returned.The investigation was confirmed for device-device incompatibility and a puncture in the catheter, as a portion of the guidewire was found to be uncoiled and was puncturing through the catheter.The definitive root cause could not be determined based upon the available information.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.(b)(4).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 or Problem Description
It was reported that the recanalization catheter allegedly became stuck on the guidewire during use in the right posterior tibial.The recanalization catheter and the guidewire were removed together as a single unit from the patient and access was lost at the lesion site.Reportedly, the procedure was completed with another guide wire and catheter.There was no reported patient injury.

• Brand Name: CROSSER RECANALIZATION CATHETER
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6207534
• Report Number: 2020394-2016-01207
• Device Sequence Number: 19064853
• Product Code: DQY
• UDI-Device Identifier: 10801741125567
• UDI-Public: (01)10801741125567(17)180828(10)GFAV3255
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K072776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2018
• Device Catalogue Number: CRU14SA
• Device Lot Number: GFAV3255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 01/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 77