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

Model Number	G06074
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non - healthcare professional - distributor.Pma/510(k) number: pre-amendment.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, prior to patient contact, a torcon nb advantage angiographic catheter slid from the package.The bottom of the package was reportedly not sealed.The device did no t make contact with the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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
Investigation/evaluation: reviews of the complaint history, device history record, instructions for use (ifu), quality control procedure, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one hnb5.0-38-100-p-ns-vert device was returned in its original packaging for investigation; however, the chevron seal was opened.The bottom seal was intact.There was evidence that the package was sealed, but the chevron adhesive transfer on the plastic film was inconsistent and not complete.The dot matrix on the tyvek side had sections in the seal area where it was not completely merged.The side rail seals were completely sealed, and when they were pulled back, there was resistance indicating an adequate seal.The catheter had been removed from the tray and the tray was placed back in the pouch in the incorrect direction.This position was consistent with the customer¿s testimony that the device slid out of the packaging.Additionally, a document based investigation evaluation was performed.There is 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 specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device which states ¿sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile." based on the information provided and the examination of the returned product, investigation has concluded that this event could be traced to a manufacturing supplier deficiency.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.Measures are being conducted to address this failure mode.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: 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: 8907440
• Report Number: 1820334-2019-02038
• Device Sequence Number: 19512265
• Product Code: DQO
• UDI-Device Identifier: 00827002060746
• UDI-Public: (01)00827002060746(17)220514(10)9707471
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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
• Operator of Device: Health Professional
• Device Model Number: G06074
• Device Catalogue Number: HNB5.0-38-100-P-NS-VERT
• Device Lot Number: 9707471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1