MAUDE Adverse Event Report: COOK ENDOSCOPY ACROBAT® 2 CALIBRATED TIP WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number AWG2-35-260

Device Problems Accessory Incompatible (1004); Entrapment of Device (1212); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the subject wire guide and an fs-omni in the wire guide holder.The wire guide is kinked approximately 184.5 cm from the distal end.Rippling and twisting of the fs-omni catheter was also observed, indicating difficulty preforming separation of the wire guide lumen/zip exchange.Since the wire guide lumen was returned fully utilized, functional testing of the wire guide lumen separation was unable to be performed.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.In the report, it was not stated if the wire was lubricated prior to use.The instructions for use states: "prior to removing wire guide from holder, flush with 30 cc of sterile water.Flush endoscope accessory channel and/or lumen of device with sterile water, then insert wire guide floppy end first.Angled tip wire guides are not recommended for front loading through these adapters.Note: for best results, wire guide should be kept wet, if applicable." prior to distribution, all acrobat 2 calibrated tip wire guide 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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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 Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook acrobat 2 calibrated tip wire guide.The physician tried to strip [exchange] the wire guide and the wire guide was stuck in the lumen of the cook fusion omni-tome sphincterotome (fs-omni).This event was not reportable at the time.Additional information was received on 19-nov-2020 noting that common bile duct (cbd) access was achieved when the wire became stuck and a new wire guide and sphincterotome had to be used to complete the procedure, indicating that wire guide access was lost [subject of this report].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.

Manufacturer Narrative

Rationale for the decision to cease reporting to the fda for loss of wire guide access to the bile duct (requiring re-cannulation) for biliary wire guides product codes ocy and kns: cook endoscopy biliary wire guides are intended to be used to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during endoscopic retrograde cholangiopancreatography (ercp).Cook endoscopy sphincterotomes with pre-loaded wire guides are intended to be used for cannulation of the ductal system and for sphincterotomy and aid in bridging difficult strictures during ercp.During an ercp, access to the biliary and pancreatic ducts can be achieved by using a standalone wire guide or a wire guide pre-loaded into a sphincterotome.Once access to the biliary or pancreatic duct is achieved, wire guides can be used to selectively cannulate confluent ducts and deliver therapeutic accessories via monorail to address a large variety of disease, metabolic, or physiologic conditions.The wire guide allows for continuous access to the desired duct.If access to the duct is lost and requires re-cannulation, or if both the accessory device and the wire guide become stuck to one another requiring complete removal from the duct and subsequent re-cannulation, this is considered lost wire guide access.A serious injury related to loss of wire guide access has not occurred in nine (9) years at the time of this notification.Since the precedent event, this malfunction has not caused or contributed to a subsequent serious injury out of (b)(4) total events reported in nine (9) years.Thus, there is a remote occurrence rate of (b)(4)% for a serious injury since the precedent event was reported.Therefore, it is concluded that the likelihood that loss of guide wire access requiring re­-cannulation will cause or contribute to a serious injury is remote.In conclusion, mdr reporting of this malfunction has ceased.Resumption of mdr reporting of this malfunction will be triggered if there is recurrence of a serious injury or death for the same malfunction.

• Brand Name: ACROBAT® 2 CALIBRATED TIP WIRE GUIDE
• Type of Device: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 11004507
• MDR Text Key: 247019565
• Report Number: 1037905-2020-00551
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002476148
• UDI-Public: (01)10827002476148(17)220313(10)W4191244
• Combination Product (y/n): N
• Reporter Country Code: ZA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2022
• Device Catalogue Number: AWG2-35-260
• Device Lot Number: W4191244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK FUSION OMNI-TOME SPHINCTEROTOME (FS-OMNI).; ERBE ELECTROSURGICAL GENERATOR, ICC 200.; OLYMPUS EVIS EXERA 3 ENDOSCOPE, CV-190.
• Patient Sex: Male