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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: thscf-35-180-1.5-rosen; cxi-4.0-35-90-p-ns-0; cmw-14-300-12g; mpis-401-pedal-nt-u-sst; jcd5.0-35-20; hpwa-35-260.Occupation: unknown.Pma/510(k): pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a micropuncture traditionless stiffened cannula access set was used in an unknown patient for an angioplasty on (b)(6) 2019.The user reports, ¿a patient came back in with sepsis¿.The infection was identified as streptococcus agalactiae group b, requiring treatment with antibiotics.As reported, there were several other cook devices used in the initial procedure and are captured under the following report reference numbers: 1820334-2019-01171 (this report), 1820334-2019-01172, 1820334-2019-01173, 1820334-2019-01174, 1820334-2019,01175, 1820334-2019-01176, 1820334-2019-01177.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation - evaluation.Reviews of the device history record, device history record, documentation, manufacturing instructions, quality control, 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 potentially contribute to this failure mode.That nonconformance was for foreign matter.However, the affected units were reworked and then processed through quality control.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.Through these reviews, cook has concluded that appropriate controls are in place to address the reported failure mode prior to distribution.It should be noted that an ifu is not provided with this device.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: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8598091
• MDR Text Key: 144668192
• Report Number: 1820334-2019-01171
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002480032
• UDI-Public: (01)00827002480032(17)220227(10)9556160
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: N/A
• Device Catalogue Number: MPIS-401-10.0-SC-NT-SST
• Device Lot Number: 9556160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening