MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY HARD WIRE BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number MWB-2X4

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter; occupation: non-healthcare professional.Investigation evaluation: a product evaluation was performed only by the picture provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photo describing the event.The lot number provided in the photo matches this report.The label in the photo matches the product reported.The picture confirms the reported occurrence.The picture provided shows the distal end of the device, and the basket has detached from the drive wire.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 conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all memory hard wire baskets are subjected to a visual inspection 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 continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook memory hard wire basket.User [physician] took the basket [to] capture a large stone after multiple stone retraction, and rotated the endoscopy[endoscope] to retract the stone while found out [discovered] the basket wire broken [broke].User [physician] changed to another same device to complete the procedure.It was reported that a section of the device did remain inside the patient¿s body; however a photo was provided of the detached portion outside the patient.It is unknown how the detached portion was retrieved.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Continued: section e.Initial reporter; occupation: non-healthcare professional.Investigation evaluation: the product said to be involved was returned in a bio bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.A photo was also provided and the lot number provided in the photo matches this report.The label in the photo matches the product reported.The photo shows the distal end of the device, and the basket has detached from the drive wire.Our laboratory evaluation of the product said to be involved confirmed the report.The basket has detached from the drive wire, but was included in the device return.The drive wire also returned within the racetrack, but was missing the catheter and the handle assembly.An unknown brown substance was observed on the crimp near the proximal end, and a white hair-like substance was observed near the crimp on the detached basket.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A meeting with production management and supervision was held on 08/30/2021 where the broken wires and basket were examined under magnification.It could not be determined how the basket tip detached.Evidence of sufficient solder was observed.No other anomalies were detected.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 conclusion: a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.The basket has detached from the drive wire.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Prior to distribution, all memory hard wire baskets are subjected to a visual inspection 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 unusual 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 continue 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): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 12333813
• MDR Text Key: 267045645
• Report Number: 1037905-2021-00390
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002220024
• UDI-Public: (01)10827002220024(17)240106(10)W4423475
• Combination Product (y/n): N
• PMA/PMN Number: K851965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2024
• Device Catalogue Number: MWB-2X4
• Device Lot Number: W4423475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE - OLYMPUS 206
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR