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

Model Number	G11457
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: k173289.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an aortogram of a superficial femoral artery occlusion in a male patient with peripheral artery disease, the cook beacon tip torcon nb advantage angiographic catheter separated at the hub while in the patient.Following the separation, the catheter was removed from the patient without difficulty, and an alternate catheter was used to complete the procedure.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
Information not included on original report: e1: customer name and address: dr.(b)(6).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
No additional information regarding the event description has been received since the last med watch report was sent.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Initial report: as reported, during an aortogram of a superficial femoral artery occlusion in a male patient with peripheral artery disease, the cook beacon tip torcon nb advantage angiographic catheter separated at the hub while in the patient.Following the separation, the catheter was removed from the patient without difficulty, and an alternate catheter was used to complete the procedure.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, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection as well as dimensional verification of the returned device were conducted during the investigation.The visual inspection of the returned device noted one used hnbr5.0-38-100-p-ns-kmp with the hub separated from the catheter was provided for investigation.Biomatter was present on the hub and shaft.The strain relief was not removed.The hub was checked for any shaft material in the strain relief.However, no shaft material was visible inside of the hub.No other surface damage was noted to the device.Additionally, a document-based investigation evaluation was performed.The evidence indicates the product was 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 and quality control procedures were conducted, and no gaps were discovered.An ifu is provided with this device, which states ¿if resistance is encountered during manipulation, stop and determine the cause before proceeding any further.¿ at this time, investigation has concluded that a definitive root cause could not be determined.However, based on the information provided and the examination of the returned product a possible cause of this failure could be the patient pre-existing pad.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
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9109400
• Report Number: 1820334-2019-02394
• Device Sequence Number: 11530596
• Product Code: DQO
• UDI-Device Identifier: 00827002114579
• UDI-Public: (01)00827002114579(17)210624(10)9813177
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2021
• Device Model Number: G11457
• Device Catalogue Number: HNBR5.0-38-100-P-NS-KMP
• Device Lot Number: 9813177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 09/17/2019; 03/06/2020
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/14/2019; 03/16/2020
• Patient Sequence Number: 1