MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma# - k142301.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The user facility reported a perforation at the upper superior vena cava (svc).The physician originally started the procedure by using two different devices from another manufacturer.It was reported that both devices failed to remove the lead.The physician switched to the lead extraction evolution mechanical dilator sheath set.There was a five minutes gap reported between the use of the other devices and the lead extraction evolution mechanical dilator sheath set.It was reported that the physician was able to extract the lead with the lead extraction evolution mechanical dilator sheath set.However, one minute post extraction, the patient¿s blood pressure dropped and transesophageal echocardiography (tee) showed massive bleeding.It was reported that an immediate insertion of the device from another manufacturer stopped the bleeding and the patient¿s chest was opened for a surgical solution.Several inquiries were made about the lot number and expiration date of the device, however at this time no further information is available about the product that was used.Therefore, it is unknown if the physician actually used expired product.Patient outcome is unknown as information not provided by reporter.

Manufacturer Narrative

Investigation - evaluation: a review of documentation, and complaint history was conducted during the investigation.The complaint device was not returned therefore physical examination of the device by the quality engineering and/or engineering departments could not be performed.A device history record review could not be performed as the complaint lot number was not provided.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
• Type of Device: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 4128458621
• MDR Report Key: 6489986
• MDR Text Key: 72738525
• Report Number: 2522007-2017-00013
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LR-EVN-13.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: 05/16/2017
• Supplement Dates FDA Received: 07/12/2017
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention