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

Catalog Number CRUO14SA

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316); Retraction Problem (1536); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 05/28/2015

Event Type  Injury  

Event Description

It was reported that the guidewire was difficult to insert into the recanalization catheter, however, it did insert.After successful use in the peroneal artery, the catheter was difficult to retract and had to be forcefully removed, causing the distal tip to detach and imbed in a calcific area.There were no attempts to retrieve the tip.Although there was no reported patient injury, the patient did experience pain during the retraction of the device.

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 presents 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.

Manufacturer Narrative

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 device was returned.The distal tip and marker band were missing and not returned with the device.A portion of the distal end of the outer catheter was also not returned with the device.The core wire remaining within the catheter was measured to be 145.9cm, measured from the detached distal tip to the strain relief.The distal end of the outer catheter and inner catheter were jagged and stretched, likely indicating that excessive force contributed to the tip detachment.Bunching was noted to the outer catheter.Photo review: one electronic photo was returned and reviewed.The photo shows the distal ends of two crosser catheters held up against a ruler.No anomalies are noted to the catheter in the far left of the photo.The catheter to the right in the photo is missing its distal metal tip, marker band, and a portion of the outer catheter.The inner guidewire lumen and core wire are protruding out the distal end of the catheter.Based upon the photo provided, a detached distal tip, marker band, and portion of the outer catheter can be confirmed.The reported issues loading the guidewire could not be confirmed.Conclusion: the investigation is confirmed for a tip detachment, marker band detachment and catheter detachment as the distal end of the catheter was not returned for evaluation.The investigation is inconclusive for issues loading the guidewire through the catheter, as guidewire patency testing could not be performed due to the condition of the returned device (i.E.Detached tip).Per the reported event details, the tip of the catheter got stuck in a calcified area during removal.It is likely that excessive force during removal of the catheter, combined with the tip being stuck, resulted in the tip detaching from the catheter.The definitive root cause for the tip getting stuck in the calcified area is unknown.The definitive root cause for the difficulty loading the guidewire through the catheter is unknown.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the crosser recanalization catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.

• Brand Name: CROSSER 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 2045
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4895910
• MDR Text Key: 20721794
• Report Number: 2020394-2015-00985
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: CRUO14SA
• Device Lot Number: GFZB0141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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 Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 114