MAUDE Adverse Event Report: COOK ENDOSCOPY ACROBAT¿ CALIBRATED TIP WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	G34266
Medical Device Problem Codes	Peeled/Delaminated (1454); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook tri-tome pc triple lumen sphincterotome, tri-25m-p.This investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat calibrated tip wire guide.The wire guide and a cook tri-tome pc triple lumen sphincterotome (tri-25m-p) were advanced to the desired position (bile duct), and after one (1) minute the surface of wire guide peeled off [coating damage].The user retracted the wire guide and sphincterotome together [loss of wire guide access] from the patient and used another of the same product to finish 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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat calibrated tip wire guide.The wire guide and a cook tri-tome pc triple lumen sphincterotome (tri-25m-p) were advanced to the desired position (bile duct), and after one (1) minute the surface of wire guide peeled off [coating damage].The user retracted the wire guide and sphincterotome together [loss of wire guide access] from the patient and used another of the same product to finish 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.
Additional Manufacturer Narrative
Cook tri-tome pc triple lumen sphincterotome, tri-25m-p.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.Approximately 16.9 to 26.7 cm from the distal end was a section of bare core wire.Approximately 14.8 cm to 16.9 cm from the distal end, the wire guide covering folded over itself.A section of the coating approximately 7.6 cm long was frayed and hanging from the wire guide, the coating was still attached at approximately 14.8 cm from the distal end.The wire guide was bent at the tip to approximately 1.9 cm from the distal end.The wire guide was also bent approximately 5.7 cm to 7.8 cm and 18.6 cm to 26.0 cm from the distal end.Rough surfaces were found throughout the entire length of the wire guide.Due to the condition of the returned device it could not be determined if any sections of the coating were missing.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 wire guide subassembly lots were reviewed.The wire guide subassembly device history records contain nonconformances that could potentially be related to wire guide damage.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.A discrepancy or anomaly was not observed with the product that was released for 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.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.Coating damage contributes to loss of wire access.Prior to distribution, all cook acrobat calibrated tip wire guides 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 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: ACROBAT¿ CALIBRATED TIP WIRE GUIDE
• Common Device Name: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8430032
• Report Number: 1037905-2019-00135
• Device Sequence Number: 1628285
• Product Code: OCY
• UDI-Device Identifier: 00827002342668
• UDI-Public: (01)00827002342668(17)210201(10)W4026327
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 02/01/2021
• Device Model Number: G34266
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4026327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS TJF-260V ENDOSCOPE.
• Patient Age: 67 YR
• Patient Weight: 53