MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM; CLAMP, VASCULAR

Catalog Number C-HSK-3043

Device Problem Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

On 08/10/2017 10:18 am (gmt-4:00) added by(b)(4).Internal complaint number trackwise(b)(4).(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal did not deploy properly, so they removed it.Case was completed with a partial occluder clamp.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal did not deploy properly, so they removed it.Case was completed with a partial occluder clamp.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.Signs of clinical usage and evidence of blood were observed.The delivery device was returned outside the loading device.Blood was observed on the loading device.The tension spring assembly and seal were not returned for investigation and the position was unable to be determined.The blue slide lock was dis-engaged and the white plunger was fully depressed on the delivery device.Blood was visible in the delivery device indicating that there was attempt to deploy the device into the aorta.Based on the received condition of the device we were not able to measure the delivery tube dimensions.The reported complaint ¿failure to deploy¿ was not confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal did not deploy properly, so they removed it.Case was completed with a partial occluder clamp.The hospital did not report any patient effects.

• Brand Name: HS III PROXIMAL SEAL SYTEM 4.3MM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 6792710
• MDR Text Key: 82634870
• Report Number: 2242352-2017-00772
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2018
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25131800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/14/2017
• Supplement Dates Manufacturer Received: 08/25/2017; 08/25/2017
• Supplement Dates FDA Received: 08/31/2017; 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 55