MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number FS-OMNI-ACRO-35-260

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: fogarty xl balloon, unknown model; cook titan balloon, unknown model; cook oasis 10 fr stent introduction system, unknown model.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record for the subassembly wire guide associated with the lot number said to be involved was reviewed.A nonconformity that could be related to the observation reported by the user was found in the device history review for coating damage.A review of the specification was conducted and a 100% visual inspection of the coating on the wire guide is performed and inspects for any damage or deformities.This inspection process would have removed any products having this nonconformance prior to distribution.Therefore, 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: 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.The instructions for use advise the user that the wire guide should be kept wet for best results.The instructions for use describe the appropriate flushing techniques for use of this coated wire guide.These techniques described include, flushing the endoscope accessory channel and/or lumen of accessory device with sterile water before wire guide insertion.If these flushing techniques are not followed or inadequate flushing occurs, this can contribute to wire guide coating damage.Prior to distribution, all fusion pre-loaded with acrobat 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 Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded with acrobat wire guide.The wire guide peeled [coating damage] at 27 centimeters during the stent implant and a piece of the wire guide was broken.During the procedure the physician felt some resistance during devices exchange.We take [retrieved] the hydrophilic covering, not the wire.The physician take out [retrieved] the hydrophilic cover part with a forceps.The [detached] part was in the duodenal area.

Manufacturer Narrative

Concomitant medical products: fogarty xl balloon, unknown model; cook titan balloon, unknown model; cook oasis 10 fr stent introduction system, unknown model.Investigation evaluation: the laboratory evaluation of the returned piece of the device confirmed the report.A piece of the distal coating material on the wire guide detached from the wire guide, approximately 2.5 cm of material.It is not known where the piece of material detached from as the entire wire guide was not returned for evaluation.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis.The device history record for the subassembly wire guide associated with the lot number said to be involved was reviewed.A nonconformity that could be related to the observation reported by the user was found in the device history review for coating damage.A review of the specification was conducted and a 100% visual inspection of the coating on the wire guide is performed and inspects for any damage or deformities.This inspection process would have removed any products having this nonconformance prior to distribution.Therefore, 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.The instructions for use advise the user that the wire guide should be kept wet for best results.The instructions for use describe the appropriate flushing techniques for use of this coated wire guide.These techniques described include, flushing the endoscope accessory channel and/or lumen of accessory device with sterile water before wire guide insertion.If these flushing techniques are not followed or inadequate flushing occurs, this can contribute to wire guide coating damage.Prior to distribution, all fusion pre-loaded with acrobat 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 Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded with acrobat wire guide.The wireguide got peeled [coating damage] at 27 centimeters during the stent implant and a piece of the wire guide was broken.During the procedure the physician felt some resistance during devices exchange.We take [retrieved] the hydrophilic covering, not the wire.The physician take out [retrieved] the hydrophilic cover part with a forceps.The [detached] part [wire guide coating] was in the duodenal area.On 12/31/2015, we received confirmation that the wire guide tip did not detach, only the biocompatible hydrophilic coating detached.

• Brand Name: FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): 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: 5325573
• MDR Text Key: 34303497
• Report Number: 1037905-2015-00554
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-OMNI-ACRO-35-260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2015
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• 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