MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. MEMORY HARD WIRE BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number MWB-3X6

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 12/27/2013

Event Type  Injury  

Event Description

During an endoscopy procedure, a cook memory hard wire basket was used.While retrieving the stones, the basket wire disconnected at the weld point [basket detached from the drive wire].The disconnected portion of the basket was retrieved with a dilation balloon and biopsy forceps.No harm to the pt.Another device of the same type was used to complete the procedure.A section of the device did not remain inside the pt's body.The physician removed the disconnected portion of the basket using a dilation balloon and biopsy forceps.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: our evaluation of the returned device confirmed the report.The basket has detached from the drive wire at the basket side of the drive wire to basket cannula.The securing assembly was examined under magnification.The basket wire securing assembly on the returned device was offset approximately 1.5 mm away from the basket end of the cannula towards the middle of the cannula.The distal 1.5 mm did not exhibit any signs of a securing assembly.An adequate basket securing assembly should be along the entire length of the cannula.The basket wires measured with specification.The outer diameter (od) of the cannula measured within specification.The inner diameter (id) of the cannula was pin gauged on the absent securing assembly 1.5 mm end and was found to be within specification.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusions: the most likely root cause of this report is an inadequate security assembly during the basket attachment process.Prior to distribution, all memory hard wire baskets are subjected to a visual inspection, manual tug and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment quality assurance will continued to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: MEMORY HARD WIRE BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, manager ; 4900 bethania station road; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 3644805
• MDR Text Key: 4287734
• Report Number: 1037905-2014-00027
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/02/2014

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: 06/11/2016
• Device Catalogue Number: MWB-3X6
• Device Lot Number: W3296597
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/27/2013
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/02/2014
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 72