MAUDE Adverse Event Report: COOK ENDOSCOPY D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number	DASH-ACRO-35-450
Medical Device Problem Codes	Peeled/Delaminated (1454); Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook fusion quattro extraction balloon, fs-qeb-a.Erbe electrosurgical generator.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.There is wire guide coating damage near the distal end.The wire guide tip was bent approximately 3.5 cm from the distal end.Wire guide coating had peeled approximately between 24 cm and 26.6 cm from the distal end exposing bare core wire.Wire guide coating had bunched up and frayed approximately 24 cm from the distal end.Due to the condition of the returned device, it cannot be determined if any sections of the coating are missing.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The subassembly device history record for the wire guide subassembly lot number said to be involved was reviewed.A nonconformance was observed that could be related to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.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 user indicated contrast was used to flush the wire guide.A possible contributing factor to wire guide damage is if contrast is used to keep the wire guide wet instead of sterile water.Contrast could solidify after considerable passage of time, subsequently resulting in wire guide damage.The user is advised with the following statement from the instructions for use: "flush injection port with sterile water.For best results, wire guide should be kept wet." 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 damage.Prior to distribution, all d.A.S.H.Pre-loaded with acrobat wire guide sphincterotomes are subjected to a visual inspection and functional test 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: 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 contrast was used flush the wire guide instead of sterile water, 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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook d.A.S.H.® pre-loaded with acrobat wire guide.They did a sphincterotomy.They removed the sphincterotome and left the wire in place.They proceeded to put the extraction balloon on the wire.They felt resistance but kept on pushing the balloon over the wire.A portion of the coating then stripped off of the wire inside the patient (subject of this report).They stopped and pulled everything out [lost wire guide access].The coating did not detach from the wire and came out with the wire.Nothing remained in the patient.They then used another wire to successfully complete the procedure.The customer said that the problem experienced, occurred three (3) other times over the holidays from unknown lots (see related mdr 1037905-2019-00048).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.® PRE-LOADED WITH ACROBAT WIRE GUIDE
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8319867
• Report Number: 1037905-2019-00047
• Device Sequence Number: 1370906
• Product Code: KNS
• UDI-Device Identifier: 10827002347783
• UDI-Public: (01)10827002347783(17)211101(10)W4138994
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K901443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2021
• Device Catalogue Number: DASH-ACRO-35-450
• Device Lot Number: W4138994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1