MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	G07913
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.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
It was reported, a patient of unknown gender and age was undergoing a leg angiography procedure utilizing a performer introducer for initial access into the common femoral artery.The device had been in place approximately five minutes when they withdrew the dilator and noted the wire had punctured the dilator in the midshaft region.It appeared the dilator material was very thin.The patient's anatomy was not tortuous, calcified, or scarred.The procedure was completed without any adverse effects to the patient.
Additional Manufacturer Narrative
Additional information: reportedly, the patient associated with mdr#1820334-2019-00603 and the patient from mdr#1820334-2019-00611 were noted to be the same.Confirming that the these events occurred on the same day, with the same patient, in the same procedure.Investigation ¿ evaluation.Reviews of the complaint history, device history record, and quality control procedures of the device were conducted during the investigation.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 shows no nonconforming events which could contribute to this failure mode.It should also be noted that only one other complaint was discovered for this lot number and it was from the same facility in the same day and the failures were identical.Furthermore, reviews of the device master record and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded that a root cause for this event could not be established.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: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8426231
• Report Number: 1820334-2019-00611
• Device Sequence Number: 303635
• Product Code: DYB
• UDI-Device Identifier: 00827002079137
• UDI-Public: (01)00827002079137(17)211205(10)9306818
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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 Expiration Date: 12/05/2021
• Device Model Number: G07913
• Device Catalogue Number: RCF-4.0-35-J
• Device Lot Number: 9306818
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1