MAUDE Adverse Event Report: COOK INC MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	MCIS-5.0-35-130-15.0
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 5fr ((b)(4)) terumo introducer, terumo stiff guidewire, amplatz superstiff guidewire.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, the multi-sideport dual check valve catheter infusion set displayed "an excessive elastic elongation with risk of rupture" upon removal from the patient's anatomy.During the procedure to treat a right femoral-popliteal obstruction with local fibrinolytic treatment, there was difficulty in advancing the complaint device from the humeral access to the right femoral-popliteal obstruction.Per the complainant, the patient had diffuse aortic and iliac calcifications but no tortuosity of the vasculature.After removal of the complaint device, the procedure was completed using a second catheter of the same type.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.According to the complainant, the complaint device will not be returned to the manufacturer for investigation.
Additional Manufacturer Narrative
Investigation-evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there was one other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7814063
• Report Number: 1820334-2018-02499
• Device Sequence Number: 1707428
• Product Code: DQO
• UDI-Device Identifier: 00827002064256
• UDI-Public: (01)00827002064256(17)200918(10)8154876
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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: 09/18/2020
• Device Catalogue Number: MCIS-5.0-35-130-15.0
• Device Lot Number: 8154876
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 65