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

Model Number G08699

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: 5fr sheath (terumo), colored syringes (merit), and glide wire (manufacturer not specified).Initial reporter occupation: non-healthcare professional.Pma/510(k) number = k173289.A photo of the complaint device was provided by the cook representative which showed a crack in the luer lock but no evidence of material separation.The device reportedly will be returned for investigation and a complete inspection will be performed.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or when additional relevant information becomes available.

Event Description

It was reported, during a cerebral angiogram and left common carotid fistula embolization procedure involving a female patient of unknown age, the hub of a beacon tip torcon nb advantage angiographic catheter cracked and a piece of the proximal luer lock broke off.Access was gained via the right groin with an unspecified five french (fr) sheath with the malfunction occurring towards the beginning of the procedure while attaching a syringe.The complainant reported there was some tortuosity in the common carotids but, overall, not a difficult angiogram or access.The complaint device was removed without resistance and replaced with another of the same device.The procedure was successfully completed with no adverse effect to the patient.No additional procedures were required as a result of his event.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, manufacturer¿s instructions, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one beacon tip torcon nb advantage angiographic catheter was returned for investigation.A crack was confirmed on the fitting of the hub.Biomatter was also noticed inside the hub.However, no further defects were noted.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, specifications, and quality control procedures were conducted, and no gaps were discovered.An ifu was also provided with this device which stated to ¿inspect the packaging and device to verify no damage.Do not use the product if the catheter or packaging is damaged.¿ moreover, it should be noted that a supplier investigation was performed on the complaint device as cook obtains this from a third-party vendor.The supplier noted that ¿the photos included in the report depict a significant amount of load being applied to the hub.The exertion of these forces contributed to the failure.¿ based on the information provided and the examination of the returned product, investigation has concluded that this event was likely due to unintended use error or an issue with the transportation of the device.Cook has reviewed and confirmed that there is no evidence to suggest the product left our facility outside of specification.Additionally, the supplier investigation revealed that excessive force had been applied to the device.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8503805
• MDR Text Key: 141619902
• Report Number: 1820334-2019-00878
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002086999
• UDI-Public: (01)00827002086999(17)210114(10)9413250
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

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: 01/14/2021
• Device Model Number: G08699
• Device Catalogue Number: HNBR5.0-35-100-P-NS-DAV
• Device Lot Number: 9413250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 98