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

Catalog Number MWB-2X4

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation continued: unknown.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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.If excessive force is applied, basket breakage can occur near the soldered joint.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.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 memory hard wire basket.The user completed the first stone removal and then retracted the device from the duodenal papilla where the user found out that the basket wire was broken [subject of report].The user then retracted the device with the endoscope from the patient carefully.The user changed to another one of the same devices to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a memory hard wire basket.The user completed the first stone removal and then retracted the device from the duodenal papilla where the user found out that the basket wire was broken [subject of report].The user then retracted the device with the endoscope from the patient carefully.The user changed to another one of the same devices to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully extended out of the catheter lumen.There was no fluid in the catheter lumen.One of the wires on the basket had broken loose from the proximal end of the basket and was still attached at the distal end of the basket.The basket extended and retracted freely with no sign of resistance, though the wire that detached remained outside of the lumen.The basket wire was broken near the soldered joint; there was no evidence of the wire being damaged during manufacturing.The basket was intact and no part of the device was missing.No other anomalies were detected.A meeting with production management and supervision and it was confirmed that the wire had not been damaged during manufacturing, and no part of the device was missing.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 this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The basket wire broke near the soldered joint.If excessive force is applied, basket breakage can occur near the soldered joint.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.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, URETAL STONE DISLODGER
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10460017
• MDR Text Key: 205527292
• Report Number: 1037905-2020-00338
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002220024
• UDI-Public: (01)10827002220024(17)220212(10)W4178298
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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: 02/12/2022
• Device Catalogue Number: MWB-2X4
• Device Lot Number: W4178298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS DUODENOSCOPE, 290
• Patient Age: 57 YR
• Patient Weight: 65