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

Model Number	G02972
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Pma/510(k) number = pre-amendment.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 or Problem Description
It was reported, during an unspecified procedure, the micropuncture transitionless pedal access set was dropped onto the foot of the patient table and a hair was observed on the device.It is unknown if the hair was on the device prior to the drop onto the table.The device was not used.
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
Additional information: investigation - evaluation.Reviews of the complaint history, device history record, manufacturer¿s instructions, quality control procedures, and specifications 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 one nonconforming event which could have contribute to this failure mode.This nonconformance was for foreign matter during manufacturing.However, the effected unit was reworked prior to order completion.Additionally, the reported failure was noted after the user dropped the device, so it is unlikely that these two nonconformances are related.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.Based on the information provided and no product returned, investigation has concluded that a root cause for this event could not be established.Reportedly, the customer is uncertain if the foreign matter was present on the device prior to dropping it.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: MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8556641
• Report Number: 1820334-2019-00937
• Device Sequence Number: 1993263
• Product Code: DYB
• UDI-Device Identifier: 00827002029729
• UDI-Public: (01)00827002029729(17)220312(10)9585765
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2022
• Device Model Number: G02972
• Device Catalogue Number: MPIS-401-PEDAL-NT-U-SST
• Device Lot Number: 9585765
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1