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

Catalog Number	ACRO-35-450
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: boston scientific truetome 44 sphincterotome.Investigation evaluation: our laboratory evaluation of the product said to be involved determined there was coating damage on the distal tip of the wire guide.The wire was returned inside of a boston scientific truetome 44 (sphincterotome).The wire guide had been advanced 49.4 cm from the distal end of the sphincterotome.There was dried white substance, likely contrast, on the wire guide and inside of the sphincterotome.Fluid in the sphincterotome catheter suggests it had been flushed.The distal tip of the sphincterotome appears to be split.There were bends and kinks throughout the proximal end of wire guide, near the wire guide port.There was coating damage noted on the distal tip of the wire guide from 5.1 cm to 5.9 cm with core wire exposed.Resistance was initially felt while removing the wire guide from the sphincterotome.The dried white substance was removed with an alcohol wipe and then the wire guide was able to be removed with no resistance.Due to the damage on the distal end of the wire guide, the wire guide was not re-advanced into the sphincterotome after it was fully removed.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: the report of resistance when advancing the wire guide was likely caused by the coating damage on the wire guide.A definitive cause for the wire guide coating could not be determined however the split tip of the sphincterotome may have contributed to the coating damage.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 an endoscopic retrograde cholangiopancreatography (ercp) the physician used a cook acrobat calibrated tip wire guide.After sphincterotomy, the physician tried to exchange to an extraction balloon but the assistant felt much resistance in advancing the wire guide.The physician tried to lock the wire guide with the scope v system[elevator] but it did not work as well.They then removed the acrobat wire guide and used another manufacturer's wire guide to complete the procedure.There was no reportable information at this time.The device was received for evaluation on 18-oct-218 and it was determined that there was coating damage at the distal tip.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: 8060107
• Report Number: 1037905-2018-00516
• Device Sequence Number: 2745467
• Product Code: OCY
• UDI-Device Identifier: 00827002342668
• UDI-Public: (01)00827002342668(17)210418(10)W4049206
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 10/04/2018

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: 04/18/2021
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4049206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR