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

Catalog Number CRE14S

Device Problems Device Inoperable (1663); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Visual inspection: the sample was returned.The distal tip was missing and not returned with the device.The outer catheter remained intact.At the distal end of the device, the marker band was present.The core wire was broken approximately 144.6cm from the distal tip.Therefore, approximately 1.4cm of the core wire and distal tip were not returned for evaluation.The distal end of the outer catheter and inner catheter was jagged.Functional/performance evaluation: functional testing could not be performed due to poor sample condition (i.E.Tip detachment).Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the investigation is confirmed for a tip detachment, as the metal tip was missing from the distal end of the catheter.The investigation is inconclusive for device inoperable, as no functional testing could be performed due to poor sample condition (i.E.Tip detachment).The root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the event.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.Additionally, precautions and specific directions for use of the crosser cto recanalization catheter are included in the ifu.(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 Description

It was reported that the recanalization catheter did not vibrate.Reportedly, the procedure was completed with another recanalization catheter using the same capital equipment.There was no reported patient involvement.

• Brand Name: CROSSER CTO RECANALIZATION 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: 5517161
• MDR Text Key: 40946579
• Report Number: 2020394-2016-00285
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: CRE14S
• Device Lot Number: GFZG3236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2015
• 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: 55 YR
• Patient Weight: 75