MAUDE Adverse Event Report: COOK ENDOSCOPY CONQUEST TTC LITHOTRIPTOR CABLE WITH ADAPTER; LQC, LITHOTRIPTER, BILIARY MECHANICAL

Catalog Number TTCL-1

Device Problems Accessory Incompatible (1004); Use of Device Problem (1670)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

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.However, the additional information received indicated that the device was used with a another manufacture's basket.The ttcl-1 device is not recommended for use with another manufactures baskets as indicated in the instructions for use (ifu).Use of this device with an incompatible basket is the most likely cause of the reported issue.The ifu states, "used in conjunction with a side-viewing endoscope, cook endoscopy lithotripsy-compatible baskets and a soehendra lithotriptor handle.¿ it also says, ¿only specified cook endoscopy soft lithotripsy-compatible baskets are recommended for use with the conquest ttc lithotriptor cable.Refer to basket label.¿ prior to distribution, all conquest ttc lithotriptor cables with adapter are subjected to a visual inspection 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.Additional comments regarding this report: based on the information provided that the device was used with a another manufacture's basket, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During a stone extraction procedure, the physician used a cook soehendra lithotriptor handle.The nurse states that a blockage of the lithotripsy sheath in the dormia (embedded) before entering the main bile duct.We have recovered the lithotripsy cable and the calculus extractor basket but we cannot uncouple (separate) them.There was no reportable information at this time.Additional information was received on 24-feb-2021: customer opened a sealed package without problem.After making a cholangiography and a large sphincterotomy without problem, physician was ready for large stone extraction.They made a dilation with a balloon.Then they tried to use an extraction balloon, but they failed because the stone was very big.They decided to use a dormia [another manufacture's extraction basket].They inserted it into the endoscope and into the biliary duct.The endoscope position was a little difficult because of scope bending.They tried to remove the stone with the basket, but it stayed impacted, impossible to remove stone and basket.They cut the dormia to use our lithotripsy system.They opened a ttcl-1 [conquest ttc lithotriptor cable with adapter] and a slh-1 [soehendra lithotriptor handle], they inserted ttcl-1 cable in the endoscope on the dormia cable.Insertion was normal at the beginning, but the physician felt resistance when he arrived at endoscope distal head.The physician said that the ttcl was stuck on the dormia cable.He asked to the nurse to connect ttcl cable to the slh handle to obtain more pushability.The cable was not in contact with basket and they started to turn the handle to try to be in contact with the basket.It was very hard to turn the handle and finally the cable broke [subject of report].They disconnected the handle from ttcl and decided to remove ttcl from the scope.Unfortunately, ttcl was still stuck to the dormia.Situation was very stressing for all the team.The ttcl was impossible to remove and the dormie was impacted with a large stone inside.They called a senior physician for help.The senior physician decided to cut the ttcl handle connector and after that they could remove the endoscope from the patient.The ttcl and the dormia were still in the patient.The endoscope was one more time inserted into the patient, the senior physician inserted a 14mm balloon to make a papilla dilation (dormia was always impacted).After dilation, they washed a lot the biliary duct.They introduced a new dormia to un-impact the first one.The large stone was still very difficult to remove and physician used a second ttcl-1 and slh-1 on the second dormia.They broke the large stone and they could remove all devices without a problem for the patient.Finally, all is going well, examination took extra time and doctor was exhausted.A section of the device did not remain inside the patient¿s body.The patient required medical intervention where the physician had to cut the lithotriptor cable and use additional devices to remove the cable and impacted basket.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 in two separate pieces, the users indicate the ttcl cable was cut to facilitate removal.The extraction basket and accompanying drive wire cable that was attempted to be used with this device are stuck within the ttcl-1 cable.Proximal section of ttcl-1: the inner coil was exposed from the coating from approximately 14.4 cm to 32.3 cm and again at 65.7cm to 67.8cm from the tip of the proximal end.The cable has also accordioned and bent from approximately 57.0 cm to 2.5 cm from the proximal end.The extraction basket drive wire is exposed from 65.7 cm to 69.2 cm from the proximal end.The inner coil is cut at 67.8 cm and the basket drive wire cable is fractured at 69.2cm from the proximal end.Distal section of ttcl-1: the extraction basket drive wire cable on the more distal section of the device said to be involved, was exposed approximately 35.4 cm in length from the fracture location.The inner coil of the ttcl was exposed from 13.9 cm to 35.4 cm from the cut location.A metal tip basket of unknown origin was observed to be exiting the device at the distal end.It extends approximately 7.0 cm beyond the tip of the ttcl-1 device.The basket is deformed and bent.The basket also contains an unknown red/brown substance.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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: the additional information received indicated that the device was used with a dormia basket.The ttcl-1 device is not recommended for use with dormia baskets as indicated in the instruction for use (ifu).Use of this device with an incompatible basket is the most likely cause of the reported issue.The ifu states, "used in conjunction with a side-viewing endoscope, cook endoscopy lithotripsy-compatible baskets and a soehendra lithotriptor handle.¿ it also says, ¿only specified cook endoscopy soft lithotripsy-compatible baskets are recommended for use with the conquest ttc lithotriptor cable.Refer to basket label.¿ prior to distribution, all conquest ttc lithotriptor cables with adapter are subjected to a visual inspection 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.Additional comments regarding this report: based on the information provided that the device was used with a another manufacture's basket, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: CONQUEST TTC LITHOTRIPTOR CABLE WITH ADAPTER
• Type of Device: LQC, LITHOTRIPTER, BILIARY MECHANICAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11562254
• MDR Text Key: 243126650
• Report Number: 1037905-2021-00126
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 10827002254722
• UDI-Public: (01)10827002254722(17)221119(10)W4288129
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Catalogue Number: TTCL-1
• Device Lot Number: W4288129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIFE PARTNER FRANCE, WS-24-20-GL030; PENTAX ENDOSCOPE; SOEHENDRA LITHOTRIPTOR HANDLE, SLH-1
• Patient Outcome(s): Required Intervention