MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SEAL (4.5MM), 5-PACK; CLAMP, VASCULAR

Model Number HST III SEAL (4.5MM), 5-PACK

Device Problems Particulates (1451); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).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 hst iii seal (4.5mm).The sticker remains on the device body during step 4 and it becomes unusable.The new hs3045 was released, and the operation was completed successfully.The hospital did not report any patient effects.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm).The sticker remains on the device body during step 4 and it becomes unusable.(the proximal seal remained in the loading device when the user pulled out the delivery system).The new hs3045 was released and the operation was completed successfully.The hospital did not report any patient effects.

Manufacturer Narrative

H6 correction: device codes changed from particulates to fitting problem.B5 correction: the event description has been updated.Internal complaint number: (b)(4).The lot # 25150341 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The device was returned to the factory on 10/01/2020.An investigation was conducted on 10/20/2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned outside the loading device with the white plunger not depressed and the blue slide not disengaged.The seal and tension spring assembly was observed inside the loading device body.The seal and tension spring assembly was removed from the loading device.The seal and tension spring was observed to be intact, no visual defects were observed.There were no stickers on either of the loading device or the delivery device.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.195 inches, the outer diameter was measured at 0.228 inches.The length of the delivery tube was measured at 2.48 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and evaluation results, the reported failure "fitting problem" was confirmed.

• Brand Name: HSK III SEAL (4.5MM), 5-PACK
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10656724
• MDR Text Key: 210647043
• Report Number: 2242352-2020-00866
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700307
• UDI-Public: 00607567700307
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: HS-3045
• Device Lot Number: 25150341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1