MAUDE Adverse Event Report: GEISTER MEDIZINTECHNIK GMBH VALVEGATE SUTURE CATCHER; INSTRUMENTS, SURGICAL, CARDIOVASCULA

Model Number 34-7475

Device Problems Bent (1059); Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/09/2013

Event Type  malfunction  

Event Description

During a minimally invasive mitral valve procedure, the surgeon went to use the suture catcher and noticed that the tip was bent.The surgeon unbent the instrument hook by using a needle holder.When the instrument was used, the tip broke off when being pulled out of the pt.The surgeon felt that the tip may be in the subcutaneous tissue in the right chest of the pt.Tip was not retrieved.Ref mfr report number 2953686-2014-00001.

Manufacturer Narrative

We, (b)(4), have not been informed by the user or distributor of our device, but found out about this user facility report by screening maude database.The device has not been sent back for eval.According to the user report the device was misaligned and was manipulated by the user in an inappropriate way, which may have caused the breakage of the bended tip.As this was recognized before use, the user should have discarded or send back to us for repair instead of manipulating the instrument.(b)(4) is the legal mfr of this device.(b)(4) is a distributor of (b)(4) in the usa.On (b)(4) 2014 fda received a report from (b)(4) (2953686-2014-00001) replying to the initial user facility report ((b)(4)).(b)(4) did not inform (b)(4) about this event / report.This report (8010697-2014-00001) is intended to provide an official response of the legal mfr, who found out about this event by periodic maude screening.User facility reported this product stating incorrect product code dth, suture, cardiovascular, class iii.Correct product code is dws, common name instruments, surgical, cardiovascular, class i.

• Brand Name: VALVEGATE SUTURE CATCHER
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULA
• Manufacturer (Section D): GEISTER MEDIZINTECHNIK GMBH; foehrenstrasse 2; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: foehrenstrasse 2; tuttlingen 78532 ; 461966240
• MDR Report Key: 4422585
• MDR Text Key: 16452887
• Report Number: 8010697-2014-00001
• Device Sequence Number: 1
• Product Code: DTH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Type of Report: Initial
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 34-7475
• Device Catalogue Number: 34-7475
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other