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

Catalog Number C-HSK-3043

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 11/25/2016

Event Type  Injury  

Manufacturer Narrative

(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 been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during a coronary artery bypass procedure, an off pump cab, heartstring iii 4.3 proximal anastomotic device was desired by the surgeon.After palpating the ascending aorta, a soft spot was identified and periaortic tissue was dissected from site in the usual fashion in preparation for proximal anastomosis.The 4.3 aortic punch was deployed without any complications.The 4.3 heartstring was then inserted into aortotomy without complication.Once deployed in the aorta, the delivery device was gently removed.The tension device and the removal portion of the device was visible on the outside of the aorta but the device was not providing adequate hemostasis.Gentle manual repositioning of the device was performed without any success.This device was removed and an additional 4.3 hsk was deployed in the aorta with the same results.A partial occlusion aortic clamp was then placed on the aorta revealing a large shelf of calcium extending around aortotomy site.Hospital believes this is not a product failure as much as it is just a bad aorta.(1st device used in case) related to (b)(4).

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.Loading device was not returned for investigation.Delivery device was returned back with the proximal seal missing tether and tension spring.The seal was observed crack and delaminated on the outer side of the coil.Blood was visible on the seal.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.Based upon the received condition of the device, both the reported failure "leak seal" and analyzed failure "crack seal" was confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, an off pump cab, heartstring iii 4.3 proximal anastomotic device was desired by the surgeon.After palpating the ascending aorta, a soft spot was identified and periaortic tissue was dissected from site in the usual fashion in preparation for proximal anastomosis.The 4.3 aortic punch was deployed without any complications.The 4.3 heartstring was then inserted into aortotomy without complication.Once deployed in the aorta, the delivery device was gently removed.The tension device and the removal portion of the device was visible on the outside of the aorta but the device was not providing adequate hemostasis.Gentle manual repositioning of the device was performed without any success.This device was removed and an additional 4.3 hsk was deployed in the aorta with the same results.A partial occlusion aortic clamp was then placed on the aorta revealing a large shelf of calcium extending around aortotomy site.Hospital believes this is not a product failure as much as it is just a bad aorta.(1st device used in case) related to (b)(4).

• 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: 6189008
• MDR Text Key: 62839318
• Report Number: 2242352-2016-01300
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/25/2016

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 Expiration Date: 10/17/2017
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25128881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 11/25/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• 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: 71 YR