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

Model Number	G51795
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: boston scientific alliance ii inflation system.Investigation evaluation: our laboratory evaluation of the product said to be involved determined that the device had a crack and a kink in the catheter.A functional test could not be performed due to the condition of the returned device.The balloon did not appear to have been inflated.During a visual examination, a crack was observed approximately 117.2 cm from the distal end.A kink was also observed approximately 115 cm from the distal end.The pre-loaded wire guide was included in the return.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 general handling and 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.Damage to the catheter can occur if the device experiences excessive pressure during general handling.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: a review of the complaint history was conducted.Corrective action is currently being assessed and a follow up report will be sent.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 esophagogastroduodenoscopy (egd), the physician selected a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.They took the balloon to dilate and it would not blow up.Water was seen in the esophagus and the patient aspirated.They aborted the procedure and bagged [manual ventilation] the patient, because the patient desaturated [blood oxygen level dropped].They performed x-rays and the patient was admitted [to the hospital].The x-rays confirmed aspiration.Additional information was received on 21-mar-2019: the oxygen saturation of the patient is unknown, but it was low enough for the anesthesia provider to use bag support during the procedure.A section of the device did not remain inside the patient's body.The patient required manual ventilation, x-ray, and hospital admission due to this occurrence.According to the initial reporter, the patient aspirated due to this occurrence.
Additional Manufacturer Narrative
Concomitant medical products: boston scientific alliance ii inflation system.Investigation evaluation: our laboratory evaluation of the product said to be involved determined that the device had a crack and a kink in the catheter.A functional test could not be performed due to the condition of the returned device.The balloon did not appear to have been inflated.During a visual examination, a crack was observed approximately 117.2 cm from the distal end.A kink was also observed approximately 115 cm from the distal end.The pre-loaded wire guide was included in the return.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 corrective action has been initiated to reduce occurrences of catheter cracking, splitting or breaking for hbd-w devices.The product said to be involved is included in the scope of the corrective actions.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: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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 esophagogastroduodenoscopy (egd), the physician selected a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.They took the balloon to dilate and it would not blow up.Water was seen in the esophagus and the patient aspirated.They aborted the procedure and bagged [manual ventilation] the patient, because the patient desaturated [blood oxygen level dropped].They performed x-rays and the patient was admitted [to the hospital].The x-rays confirmed aspiration.Additional information was received on 21-mar-2019: the oxygen saturation of the patient is unknown, but it was low enough for the anesthesia provider to use bag support during the procedure.A section of the device did not remain inside the patient's body.The patient required manual ventilation, x-ray, and hospital admission due to this occurrence.According to the initial reporter, the patient aspirated due to this occurrence.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8488542
• Report Number: 1037905-2019-00171
• Device Sequence Number: 11233747
• Product Code: KNQ
• UDI-Device Identifier: 00827002517950
• UDI-Public: (01)00827002517950(17)200712(10)W3891585
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2020
• Device Model Number: G51795
• Device Catalogue Number: HBD-W-10-11-12
• Device Lot Number: W3891585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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 190 ENDOSCOPE; OLYMPUS 190 ENDOSCOPE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 49