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

Catalog Number	MPIS-401-SST
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that during a coronary angiogram, the sheath of the micropuncture transitionless access set got stuck in the patient 's femoral artery and had to be surgically removed.Approach for coronary angiogram procedure was made via the right femoral artery.Insertion of the complaint device was not difficult.The patient's anatomy was neither calcified, scarred, nor torturous.At an unspecified point in the procedure, the complaint device became lodged in the patient's anatomy and could not be removed via the endovascular approach.The angiogram procedure was not completed in order for the patient to be brought to the operating room where the distal portion of the complaint device (in it's entirety) was surgically removed.The removal was successful and the patient was reportedly "fine".After removal, no section of the complaint device remained inside the patient¿s body.The patient did not require any additional procedures and according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The inspection of the returned device confirmed that the hub was separated; the hub portion of the device was not returned.The segment which was returned was measured to be 9.4 cm in length.It was unclear which end of the returned segment was the proximal end of the device, and which end was the distal end.However, both ends were not smooth, and both exhibited some evidence of stretching and damage.Additionally, 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 showed the lot was released meeting all finished goods release criteria.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigational findings.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7550129
• Report Number: 1820334-2018-01364
• Device Sequence Number: 13882840
• Product Code: DYB
• UDI-Device Identifier: 00827002479401
• UDI-Public: (01)00827002479401(17)210112(10)8508000
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MPIS-401-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 07/10/2018
• 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: 65 YR