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

Model Number	G34266
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: microtech balloon device, mtn-srb-t-16/20.Occupation: non-healthcare professional.Investigation evaluation: a product evaluation was performed only by the photo provided with this report because the product said to be involved was not provided to cook for evaluation.A photo of the lot number was not provided.The report was confirmed with the photo provided.In the photo, the bare core wire of the wire guide is exposed.A portion of the wire guide coating is folded back onto itself and hanging from the wire guide.The specific location of the damage is unclear, however due to the silver makings present on the wire guide coating in the photo, it can be assumed that the damage is within the 25 cm distal tip of the device.The device history records for the wire guide lot and subassembly lots were reviewed.The wire guide device history record contains 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.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 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.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: 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 or Problem Description
During a stone removal procedure, the physician used a cook acrobat calibrated tip wire guide.The coating of the wire guide peeled off during advancement of a balloon device from another manufacturer.The user changed to a wire guide from another manufacturer immediately and completed the procedure.The photos provided from the customer indicated that the coating damage was within the first 25 cm.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 a stone removal procedure, the physician used a cook acrobat calibrated tip wire guide.The coating of the wire guide peeled off during advancement of a balloon device from another manufacturer.The user changed to a wire guide from another manufacturer immediately and completed the procedure.The photos provided from the customer indicated that the coating damage was within the first 25 cm.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
Continued from section d11: microtech balloon device, mtn-srb-t-16/20.Continued from section e3 occupation: non-healthcare professional.Investigation evaluation: in the provided photo, the bare core wire of the wire guide is exposed.A portion of the wire guide coating was folded back onto itself and hanging from the wire guide.The specific location of the damage was unclear, however due to the silver makings present on the wire guide coating in the photo, it is likely that the damage was within the 25 cm distal tip of the device.Our evaluation of the product said to be involved confirmed the report.The wire guide was kinked approximately 2.5 cm from the distal end.Approximately 5.8 cm to 12.8 cm from the distal end, the wire guide covering has folded over itself.A section of the coating approximately 0.3 cm long is frayed and hanging from the wire guide, the coating still attached at approximately 5.8 cm from the distal end.Approximately 12.8 cm to 21.4 cm from the distal end was a section of bare core wire.The wire guide was bent approximately 10.5 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 cannot 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 lot and subassembly lots were reviewed.The wire guide device history record contains 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.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.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: 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: 8656121
• Report Number: 1037905-2019-00289
• Device Sequence Number: 16602278
• Product Code: OCY
• UDI-Device Identifier: 00827002342668
• UDI-Public: (01)00827002342668(17)211002(10)W4126822
• 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): 05/05/2019

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: 10/02/2021
• Device Model Number: G34266
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4126822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/05/2019
• Supplement Date Received by Manufacturer: 05/05/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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 JF-260V ENDOSCOPE
• Patient Age: 70 YR
• Patient Weight: 60