MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	G48007
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Pma/510(k) number: k171275.(b)(4).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, during an aortogram and bilateral selective angiogram with possible intervention on (b)(6) ''209'', involving a (b)(6) year-old female patient, a micropuncture transitionless stiffened cannula access set introducer/inner cannula "stripped".The patient, weighing (b)(6) kilograms, had a medical history of ischemic cardiomyopathy, peripheral artery disease, carotid artery disease, benign hypertension, type 2 diabetes mellitus, symptomatic bradycardia with permanent pacemaker (ppm), and a former history of smoking.Successful percutaneous transluminal angioplasty of the left external iliac artery was performed.As the user attempted to access the right common femoral artery with the complaint device in order to place a larger diameter wire, the coating of the introducer reportedly became stripped.The access site was reported to be calcified.The patient was referred for vascular surgery for bilateral common femoral endarterectomies and successful removal of the introducer in the right common femoral artery.The patient reportedly experienced "some" delirium and confusion in the intensive care unit as well as decreased urinary output that was responsive to administration of intravenous fluids.The patient was discharged to a skilled nursing facility on (b)(6) 2019.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional patient or event information has been received since the last report was submitted on (b)(6) 2019.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A document based investigation was also performed including a review of complaint history, device history record, drawings, documentation, manufacturing instructions, quality control data, and specifications.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The complaint was confirmed based on customer testimony.Based on the results of the investigation the complaint was most likely caused by the calcified nature of the patient¿ s anatomy.There are no related non-conformances, no lot related complaints and adequate inspection activities are in place during manufacture, thus it was concluded that there is no reason to believe that non-conforming product from this lot exists in house or in the field.No cause for the damage to the cannula could be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8784964
• Report Number: 1820334-2019-01676
• Device Sequence Number: 2397990
• Product Code: DYB
• UDI-Device Identifier: 00827002480070
• UDI-Public: (01)00827002480070(17)220516(10)9746048
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: 05/16/2022
• Device Model Number: G48007
• Device Catalogue Number: MPIS-501-10.0-SC-NT-SST
• Device Lot Number: 9746048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 86