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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook tri-ex multiple size extraction balloon, txr-8.5-12-15-a.Occupation: non-healthcare professional.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The wire guide was kinked approximately 1.7 cm from the distal end.The wire guide was bent from approximately 10.5 cm to 27.0 cm from the distal end.Approximately 8.0 cm to 10.0 cm from the distal end, the wire guide covering has folded over itself, bunching at approximately 9.1 cm and 9.6 cm from the distal end.Approximately 10.0 cm to 27.1 cm from the distal end was a section of bare core wire.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 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.Prior to distribution, all acrobat® calibrated tip wire guides are subjected to a visual inspection and functional testing 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 user advanced the wire guide through the endoscope to be used with a cook tri-ex multiple size extraction balloon (txr-8.5-12-15-a) to remove the stone.The user found out the wire guide was kinked while removing the wire guide from the patient.The user could not remove the wire guide from the patient because of the kink issue.The user retracted the endoscope along with wire guide and extraction balloon all together from the patient [lost wire guide access].While retracting the endoscope from the patient, the hydrophilic coating of the wire guide peeled off.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.
Event or Problem Description
The following was initially reported to the fda on (b)(6) 2019: "during a stone removal procedure, the physician used a cook acrobat calibrated tip wire guide.The user advanced the wire guide through the endoscope to be used with a cook tri-ex multiple size extraction balloon (txr-8.5-12-15-a) to remove the stone.The user found out the wire guide was kinked while removing the wire guide from the patient.The user could not remove the wire guide from the patient because of the kink issue.The user retracted the endoscope along with wire guide and extraction balloon all together from the patient [lost wire guide access].While retracting the endoscope from the patient, the hydrophilic coating of the wire guide peeled off.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted." additional information was received on (b)(6) 2019 regarding the patient outcome: 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: 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: 8871554
• Report Number: 1037905-2019-00454
• Device Sequence Number: 2000269
• Product Code: OCY
• UDI-Device Identifier: 00827002342668
• UDI-Public: (01)00827002342668(17)211119(10)W4145429
• 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): 07/12/2019

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: 11/19/2021
• Device Model Number: G34266
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4145429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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 DUODENOSCOPE, UNKNOWN MODEL
• Patient Age: 56 YR
• Patient Weight: 78