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

Catalog Number CRU14SA

Device Problems Melted (1385); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records or 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 the recanalization catheter allegedly became stuck on the guidewire during use in the right anterior and posterior tibials; therefore, the catheter and guidewire were removed as a single unit, resulting in loss of access.It was further reported that upon removal of the recanalization catheter and guidewire, it was noted that the distal tip was warm and appeared to have melted to the guidewire.Reportedly, access was regained at the site with another wire and recanalization catheter and the procedure was completed.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been 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.Visual/microscopic inspection: the catheter was examined under microscopic magnification, and was observed to be bunched near the distal tip.No signs of melting were observed along the length of the catheter.No other anomalies were identified along the length of the catheter.Functional/performance evaluation: the guidewire was unable to be advanced through the catheter due to the bunching.The guidewire was retracted from the catheter without issue.The device was attached to the transducer of the in-house generator.An in-house injector pump was used to flush the device with saline.The device was able to produce vibrations throughout the entire length of the catheter.Misting was observed coming out from the distal tip, indicating that the device was vibrating properly.The distal tip of the catheter was pressed against one end of a 5mm plaster tile, and was able to penetrate the tile 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 device was returned.The complaint investigation is unconfirmed for melting of the catheter, as no signs of melting were observed along the length of the catheter and the catheter activated and passed the tile test without issue.The investigation is confirmed for device-device incompatibility based on the condition of the returned sample and the guidewire was unable to be advanced through the catheter.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.(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 allegedly became stuck on the guidewire during use in the right anterior and posterior tibials; therefore, the catheter and guidewire were removed as a single unit, resulting in loss of access.It was further reported that upon removal of the recanalization catheter and guidewire, it was noted that the distal tip was warm and appeared to have melted to the guidewire.Reportedly, access was regained at the site with another wire and recanalization catheter and the procedure was completed.There was no reported patient injury.

• 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 Key: 5943367
• MDR Text Key: 54459355
• Report Number: 2020394-2016-00865
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: CRU14SA
• Device Lot Number: GFAR2511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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: 72 YR
• Patient Weight: 74