MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER 14S CTO RX CATHETER

Catalog Number CRE14S

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2015

Event Type  Injury  

Event Description

It was reported that the marker band of the recanalization catheter allegedly detached from the catheter and remains in the patient.The marker band allegedly migrated to the dorsalis pedis artery without any serious signs of embolization; therefore, it was reported that the physician decided to leave the marker band in the patient and completed the recanalization procedure.There was no known impact or consequence to the patient.

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device had not been returned to the manufacturer for evaluation.The investigation 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.

Manufacturer Narrative

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 device was returned without product packaging or labeling.The distal tip of the catheter was present and was not detached from the core wire.The distal metal marker band was not present on the catheter and was not returned.A small segment of the marker band was still present on the outer catheter.The outer catheter and inner guidewire lumen were separated from the distal metal tip and the edges of the outer catheter separation were jagged and stretched.Bunching of the catheter was noted near the distal tip.No other anomalies were noted to the returned device.Functional/performance evaluation: no functional testing was performed due to the condition of the returned device.Medical records review: medical records were not provided.Image/photo review: no images/photos were provided.Conclusion: the investigation is confirmed for a marker band detachment, as only a small segment of the marker band was present on the catheter and the remainder of the marker band was not returned for evaluation.The investigation is confirmed for material separation, as the catheter was separated from the distal tip.Per the reported event details, the tip of the catheter got stuck at the distal end of the occlusion during removal.It is likely that excessive force during removal of the catheter, combined with the tip being stuck, resulted in the marker band detaching from the catheter and the outer catheter separating from the distal tip.The definitive root cause for the tip getting stuck in the distal end of the occlusion is unknown.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: specific warnings, precautions and adverse events associated with the use of the crosser catheter are included in the current instructions for use (ifu).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.

• Brand Name: CROSSER 14S CTO RX 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: 4947294
• MDR Text Key: 6190428
• Report Number: 2020394-2015-01218
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: CRE14S
• Device Lot Number: GFYI3088
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• 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): Required Intervention