MAUDE Adverse Event Report: COOK INC TORCON NB ADVANTAGE VAN SCHIE BEACON TIP SEEKING CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	G13793
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the tip of a torcon nb advantage van schie beacon tip seeking catheter separated in the patient during an unknown procedure.The tip of the device was removed with a snare.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.
Additional Manufacturer Narrative
Occupation- interventional radiology lead.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Occupation- interventional radiology lead.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, the tip of a torcon nb advantage van schie beacon tip seeking catheter separated in the patient during an unknown procedure.The tip of the device was removed with a snare.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.
Additional Manufacturer Narrative
H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information was received 28jan2022.Access was obtained in the right common femoral artery using an unspecified 5 french sheath, and the catheter was intended to target the celiac artery.An unspecified bentson wire was used.The iliac arteries were slightly tortuous; however, resistance was not encountered while manipulating the device.A power injector was not used.As the catheter was being removed over a wire, the catheter caught on the tip of the sheath, reportedly catching at the transition point between the catheter body and catheter tip.Contralateral access was obtained and the separated fragment was successfully retrieved with a snare.There have been no additional adverse effects to the patient.
Additional Manufacturer Narrative
Summary of event: as reported, the tip of a torcon nb advantage van schie beacon tip seeking catheter separated in the patient during an unknown procedure.Access was obtained in the right common femoral artery using an unspecified 5 french sheath, and the catheter was intended to target the celiac artery.An unspecified bentson wire was used.The iliac arteries were slightly tortuous; however, resistance was not encountered while manipulating the device.A power injector was not used.As the catheter was being removed over a wire, the catheter caught on the tip of the sheath, reportedly catching at the transition point between the catheter body and catheter tip.Contralateral access was obtained and the separated fragment was successfully retrieved with a snare.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.Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the returned device was also conducted.The device was returned to cook in the used condition.The tip of the catheter was missing.In response to this incident, cook completed a review of the device history record (dhr).The dhr for the reported lot found 2 relevant non-conformances for surface defect on 5 devices, all of which were scrapped.The dhr for a related bonded shaft subassembly lot found 1 relevant non-conformance on 27 devices for bond or shaft wires exposed, all of which were scrapped.This relevant subassembly lot was used in 4 final lots, and a search of these 4 lots found no additional complaints reported from the field.Although these non-conformances are relevant to the reported failure mode, all non-conforming product was scrapped, there are 100% inspections to capture this non-conformance.Adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: instructions for use: ¿inspect the packaging and device to verify no damage.Do not use the product if the catheter or packaging is damaged.¿ how supplied: ¿this product is sterilized by ethylene oxide gas.Catheters are supplied in a foil pouch and inner peel-open package.The outer surface of the inner package is non-sterile.Store in a dark, dry, cool place.Use immediately once foil pouch has been opened.Upon removal from package, inspect the product to ensure no damage has occurred.Intended for one-time use.¿ the returned catheter was missing the tip section of the device which was originally connected to the catheter by a bond.Cook has concluded that manufacturing deficiencies contributed to this incident.The appropriate personnel were retrained to the appropriate processes on (b)(6) 2022.Additional investigation into others lots completed by this operator revealed no other complaints have been reported from the field, thus cook believes this to be a singular event and no escalation is necessary.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: TORCON NB ADVANTAGE VAN SCHIE BEACON TIP SEEKING CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13317333
• Report Number: 1820334-2022-00099
• Device Sequence Number: 17061958
• Product Code: DQO
• UDI-Device Identifier: 00827002137936
• UDI-Public: (01)00827002137936(17)230528(10)13986882
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2022

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: 05/28/2023
• Device Model Number: G13793
• Device Catalogue Number: HNBR5.0-35-65-P-NS-VANSCHIE5
• Device Lot Number: 13986882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 01/28/2022; 04/13/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 02/23/2022; 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown