MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; KNQ, DILATOR, ESOPHAGEAL

Catalog Number HBD-W-12-13.5-15

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: merit medical big60 inflation device, olympus visiglide wire guide, unknown model.Initial reporter occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A functional test could not be performed due to the condition of the returned device.The device appeared to have been subjected to excessive pressure and was damaged in several areas.The complaint information stated that the wire stripped as the balloon was being removed from the endoscope.Responses to the additional questions indicated that the pre-loaded wire guide had been used with the balloon.A visual examination of the complaint device showed that the pre-loaded wire guide included with the device had not been used, instead another company's wire guide was stuck in the device.The wire guide stuck in the balloon appears to be an olympus visiglide wire guide.A visual examination was performed and it was observed that the catheter had broken from the rest of the device approximately 28 cm from the proximal end.The broken portion of the catheter showed kinks approximately 22.5 cm and 23.2 cm and a crack approximately 25.5 cm from the proximal end.For the other portion of the device, purple tubing had been exposed and stretched out with several kinks and bends.A portion of the blue catheter appeared to be missing.A section of the blue catheter between approximately 44.5 cm and 51 cm from the proximal end was flattened out and had several kinks and bends.The blue catheter had broken again exposing purple tubing between approximately 51 cm and 61.5 cm from the proximal end.The catheter was flattened and broken at approximately 62 cm from the proximal end.Additionally, kinks were observed in the catheter approximately 81 cm and 181.8 cm from the proximal end.The wire guide stuck in the balloon was retrieved and observed to have some damage.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 user reported the wire guide unraveled, however the pre-loaded wire guide was not returned, instead a wire guide from another manufacturer was returned.Therefore, 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.The device was returned in multiple pieces and severely damaged; therefore, the cause of the damage is unknown.Prior to distribution, all hercules 3 stage wireguided balloons esophageal-pyloric-colonic are subjected to a visual examination 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 a dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The wire [guide] stripped [unraveled] as the balloon was being removed from the endoscope.There was no reportable information at this time.The device evaluated on 16-jan-2019 and it was discovered that the wire guide used was another manufacturer's wire guide.However, the balloon catheter was broken in multiple places.In addition, a portion of the catheter appeared to be missing.This information was communicated to the user facility and the location of the missing section is unknown.The initial reporter stated that a section of the device did not remain inside the patient¿s body; however the location of the missing section detected during our laboratory evaluation is unknown.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: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• 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: 8319868
• MDR Text Key: 138219465
• Report Number: 1037905-2019-00051
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517967
• UDI-Public: (01)00827002517967(17)211002(10)W4127011
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Catalogue Number: HBD-W-12-13.5-15
• Device Lot Number: W4127011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2018
• 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