MAUDE Adverse Event Report: COOK ENDOSCOPY D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number DASH-35-480

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter; occupation: non-healthcare professional.Investigation evaluation: our evaluation of the product said to be involved confirmed the report of the wire guide coating peeling off of the distal tip.There is wire guide coating damage on the spiral coating.The coating was damaged from approximately 23.0 cm to 33.5 cm from the distal tip, with a bend in the device spanning approximately the same distance.Approximately 23.0 cm to 25.3 cm and 31.7 cm to 33.5 cm from the proximal end, the wire guide covering has accordioned.There was core wire exposed from approximately 25.3 cm to 31.7 cm.A section of the coating approximately 0.7 cm long is frayed and hanging from the wire guide, the coating still attached at approximately 31.7 cm from the distal end.A small bend was also observed at around 2.4 cm from the distal tip.No other kinks or rough surfaces were found along the length of the wire guide.Due to the condition of the returned device it cannot be determined if any sections of the coating are missing.The sphincterotome associated with this device was not included in the return of the device.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history records 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: coating damage on the wire guide contributed to loss of wire guide access.However, 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.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.If the endoscope or accessory device used with this device contains a burr, this could contribute to wire guide coating separation/damage.Prior to distribution, all cook d.A.S.H.Dometip double lumen sphincterotomes 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.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) procedure the physician used a cook d.A.S.H.Dometip double lumen sphincterotome.After they used the device to cannulate the bile duct, another manufacturer's plastic stent with introducer was placed over the wire guide.The introducer was not able to be removed, so they removed the endoscope and all devices from the patient [lost wire guide access, subject of this report].The wire guide was twisted and the coating of the wire guide fell off.A new package was used.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.

• Brand Name: D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 9804879
• MDR Text Key: 226589498
• Report Number: 1037905-2020-00129
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 10827002256665
• UDI-Public: (01)10827002256665(17)220507(10)W4212079
• Combination Product (y/n): N
• PMA/PMN Number: K901443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2022
• Device Catalogue Number: DASH-35-480
• Device Lot Number: W4212079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2019
• 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 Age: 77 YR
• Patient Weight: 75