MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number MPIS-501-10.0-SC-NT-SST

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) number = k130293.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 that during a cerebral angiogram with intervention via the right common femoral artery (cfa), the tip of the micropuncture transitionless stiffened cannula access set broke off inside the patient's anatomy.The patient was an (b)(6) female who presented with a sudden onset headache and had a computed tomography (ct) scan of the head that showed diffuse subarachnoid hemorrhage.A ct angiogram showed a complex right internal carotid artery aneurysm.Shortly after arrival at the hospital, the patient had a change in her mental status and was emergently intubated.She underwent placement of an external ventricular drain and remained comatose.The patient was scheduled for coil embolization of a ruptured right fetal posterior cerebral artery aneurysm.After gaining access to the right cfa with the micropuncture needle, a microwire was successfully advanced into the artery; however, there was marked difficulty advancing the complaint device due to significant scar tissue along the right cfa.Due to the patient's past coronary catheterizations.Subsequently, it was decided to remove the complaint device and attempt a new puncture.However, during the attempted removal, the micropuncture transitionless stiffened cannula broke and receded into the groin incision.Hemostasis of the right groin incision site was easily achieved with manual pressure.The left cfa was then accessed and a flush catheter was advanced in to the right common iliac artery where successful digital subtraction angiography was utilized to view the right groin.This showed a retained dilator at the puncture site within the right cfa.The portion of the complaint device was then successfully removed using a kelly clamp.Hemostasis was achieved using manual compression.There was no evidence of dissection or vascular injury and the right cfa arteriotomy was successfully closed with a closure device.The embolization procedure was successfully completed via the left cfa and the patient was transported to the neurology intensive care unit intubated and sedated."no immediate technical or procedural complications were encountered." according to the operative report, no section of the complaint device remained in the patient's anatomy.No adverse effects have been reported as a result of this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation: a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, and specifications of the device was 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 be noted there were no 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.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.- attachment: [pr227567_hhs_fda_3500a_1000060000-2018-8049_recvd 14may2018.Pdf].

Event 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 STIFFENED CANNULA ACCESS SET
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7531343
• MDR Text Key: 108854208
• Report Number: 1820334-2018-01440
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00827002480049
• UDI-Public: (01)00827002480049(17)210112(10)8507990
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MPIS-501-10.0-SC-NT-SST
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR