MAUDE Adverse Event Report: ABBOTT VASCULAR THE CLOSER S 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	UNK CLOSER S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994)
Date of Event	01/01/2001
Type of Reportable Event	Serious Injury
Event or Problem Description
This study investigated the safety and efficacy of the pre-closure technique using the closer device in terms of time-to-hemostasis, ambulation and patient discharge for percutaneous coronary interventions compared to prostar xl as documented in the perclose accelerated ambulation and discharge (paradise) trial.The time-to-hemostasis, ambulation and discharge of the pre-closure arm patients seemed to be comparable to those of the standard arm and the paradise trial.No major complications were reported; however, minor bleeding, hematoma and pain were reported for the closer device requiring manual compression, medication and prolonged hospitalization.Hematoma, infection with surgery, oozing requiring manual compression and prolonged hospitalization were noted for the prostar xl device in the paradise trial.In addition the prostar xl has potentially been associated with pseudoaneurysm and blood loss requiring transfusions and manual compression.The study concluded that the closer device appears to be a safe and rapid means of achieving hemostasis, ambulation and discharge and is comparable to the prostar xl device.In addition the pre-closure technique is a safe means of achieving hemostasis post-pci using large-sized sheaths without major complications.Specific patient information is documented as unknown.No additional information was provided.Article attachment: title - the safety and efficacy of "pre-closure" utilizing the closer suture-mediated vascular closure device for achievement of hemostasis in patients following coronary interventions: results of the second perclose accelerated ambulation and discharge (paradise ii) trial.
Additional Manufacturer Narrative
Estimated date the udi is not known as the part and lot number were not provided in the literature.The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other device is filed under a separate manufacturing report number.Attachment article title: the safety and efficacy of "pre-closure" utilizing the closer suture-mediated vascular closure device for achievement of hemostasis in patients following coronary interventions: results of the second perclose accelerated ambulation and discharge (paradise ii) trial.
Additional Manufacturer Narrative
D4 and h4: the device expiration and manufacturing dates could not be provided as the device lot number was not provided and the device was not returned.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the case information, a conclusive cause for the reported patient effects of, hematoma, hemorrhage, pain, and the relationship to the product, if any, cannot be determined.A definitive cause for the reported failure to achieve hemostasis could not be determined.Based on the information reported through the research article, a conclusive cause for the reported failure to achieve hemostasis could not be determined.Additionally, a definitive cause for the reported patient effects of hematoma, hemorrhage, pain, and the relationship to the product, if any, cannot be determined.The reported surgical intervention, unexpected medical intervention and medication required were likely related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.B5: description of event/ problem.
Event or Problem Description
Subsequent to previously filed report, update to information provided: this study investigated the safety and efficacy of the pre-closure technique using the closer device in terms of time-to-hemostasis, ambulation and patient discharge for percutaneous coronary interventions compared to prostar xl as documented in the perclose accelerated ambulation and discharge (paradise) trial.The time-to-hemostasis, ambulation and discharge of the pre-closure arm patients seemed to be comparable to those of the standard arm and the paradise trial.No major complications were reported; however, minor bleeding, hematoma and pain were reported for the closer device requiring manual compression, surgery, medication and prolonged hospitalization.Hematoma, infection with surgery, oozing requiring manual compression and prolonged hospitalization were noted for the prostar xl device in the paradise trial.In addition, the prostar xl has potentially been associated with pseudoaneurysm and blood loss requiring transfusions and manual compression.The study concluded that the closer device appears to be a safe and rapid means of achieving hemostasis, ambulation and discharge and is comparable to the prostar xl device.In addition the pre-closure technique is a safe means of achieving hemostasis post-percutaneous coronary intervention using large-sized sheaths without major complications.Specific patient information is documented as unknown.No additional information was provided.

• Brand Name: THE CLOSER S 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12866417
• Report Number: 2024168-2021-10786
• Device Sequence Number: 4782132
• Product Code: MGB
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P960043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK CLOSER S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown