MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (4.3MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (4.3MM)

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problems Death (1802); Laceration(s) (1946); Perforation (2001); Loss of consciousness (2418); Aortic Dissection (2491); Blood Loss (2597)

Event Date 04/03/2020

Event Type  Death  

Manufacturer Narrative

Trackwise id # (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 using hs iii system (4.3mm) malfunctioned.They were going to deploy the aortic cutter and when they deployed, the whole device came apart putting a hole across the entirety of the aorta and a hole in the pulmonary vein.The patient crashed and they had to put patient on bypass.Bypass was for 2 hours while they repaired the damage.As of (b)(6) 2020 patient is still in hospital.The aortic punch/cutter malfunctioned and instead of the usual tip of the punch coming out of the end, the device casing split open and the entire rod deployed out of the end causing a penetrating traumatic perforation through the posterior wall of the ascending aorta and the right pulmonary artery.Emergency femoral bypass was initiated and the aorta was transected to repair the aforementioned injuries.Severe coagulopathy resulted requiring significant blood product transfusion.The patient is still in the hospital at this time in the icu.Please note, the tip was bent after the injury in an effort to recap and store the damaged device.

Manufacturer Narrative

B2 correction: "outcome attributed to ae" changed to "death".H6 correction: "material twisted/bent; wire" removed from device codes.H6 correction: patient codes changed to "blood loss", "aortic dissection", and "laceration(s)".Internal complaint number: (b)(4).The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.The aortic cutter was returned to the factory for evaluation on 04/17/2020.An investigation was conducted on 06/24/2020.Signs of clinical use and heavy amounts of blood was observed on the aortic cutter.The aortic cutter housing cover was split at the joints but was not completely detached.The device was not in ¿exploded¿ state as reported by the customer.There were no components separated.There was only a split/gap identified at the joints of the housing.The blade and the needle were extended outside the cutter.An engineers evaluation was conducted.The extension of the blade was measured at 0.3875¿¿ which is within the specification.The needle was bent.Per the event description, the user inadvertently bent the needle while putting the bore cap on the cutter.The covers were separated to inspect the internal assembly.It was observed that one of the six pins located at the distal end of the cutter was broken.The broken pin was on the half that houses the spring assembly.The spring was measured and investigated for any damages.The length of the spring was measured at 4.517¿¿, the spring outer diameter was measured at 0.499¿¿ and the diameter of the spring wire was measured at 0.03577¿¿.All the measured dimensions were within the specifications.There were no non-conformities observed with the spring.Based on the return condition of the device and the evaluation result, the reported failure "break" were not confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure using hs iii system (4.3mm) malfunctioned.They were going to deploy the aortic cutter and when they deployed, the whole device came apart putting a hole across the entirety of the aorta and a hole in the pulmonary vein.The patient crashed and they had to put patient on bypass.Bypass was for 2 hours while they repaired the damage.As of (b)(6) 2020 patient is still in hospital.The aortic punch/cutter malfunctioned and instead of the usual tip of the punch coming out of the end, the device casing split open and the entire rod deployed out of the end causing a penetrating traumatic perforation through the posterior wall of the ascending aorta and the right pulmonary artery.Emergency femoral bypass was initiated and the aorta was transected to repair the aforementioned injuries.Severe coagulopathy resulted requiring significant blood product transfusion.The patient is still in the hospital at this time in the icu.Please note, the tip was bent after the injury in an effort to recap and store the damaged device.

Event Description

The hospital reported that during a coronary artery bypass procedure using hs iii system (4.3mm) malfunctioned.They were going to deploy the aortic cutter and when they deployed, the whole device came apart putting a hole across the entirety of the aorta and a hole in the pulmonary vein.The patient crashed and they had to put patient on bypass.Bypass was for 2 hours while they repaired the damage.As of (b)(6) 2020 patient is still in hospital.The aortic punch/cutter malfunctioned and instead of the usual tip of the punch coming out of the end, the device casing split open and the entire rod deployed out of the end causing a penetrating traumatic perforation through the posterior wall of the ascending aorta and the right pulmonary artery.Emergency femoral bypass was initiated and the aorta was transected to repair the aforementioned injuries.Severe coagulopathy resulted requiring significant blood product transfusion.The patient is still in the hospital at this time in the icu.Please note, the tip was bent after the injury in an effort to recap and store the damaged device.

Manufacturer Narrative

Corrected section: h-1 -type of reportable event and h-6 - patient codes.Corrected h-1 to from "serious injury" to "death".Corrected h-6 to reflect "death".Updated sections: g-4, g-7, h-2, h-10.Internal complaint number: (b)(4).

• Brand Name: HSK III SYSTEM (4.3MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10032886
• MDR Text Key: 190155326
• Report Number: 2242352-2020-00419
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2021
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: HSK-3043
• Device Lot Number: 25149846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 73 YR