MAUDE Adverse Event Report: CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL ZURPAZ 8.5F STEERABLE SHEATH; INTRODUCER STEERABLE

Model Number UNKNOWN

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

Patient Problems Embolism (1829); Thrombosis (2100)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

Additional information received 10-aug-2020: "the device will be not returned because the adverse event happened after procedure and not during it.So all single use devices used were not still available, including orion.And that's why any interventions were performed.The procedure that was been performed was an atypical flutter, but the embolic event happened 5 hours after the successful completion of the procedure.I think that probably there is no correlation between the event and use of orion, but due to policy i opened this complaint to report this event.So, the physician is dr.(b)(6) from (b)(6) hospital.The embolic episode was treated by pharmaceutical therapy and at this time it seems working well, but they don't know exactly what was the cause of this episode because it happened several hours after the procedure (an ablation of left atypical atrial flutter), not during it." if any other additional information is received at a later date, this will be reviewed, and the report will be updated accordingly in case it changes the conclusions.Investigation findings: the product was not returned for review at the time of this report being completed.The device is not available for investigation and examination.It was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device.Therefore, the primary as reported classifications of zurpaz - patient - embolism and a secondary as reported classification of zurpaz - patient - thrombus cannot be confirmed.A review of the manufacturing documentation for lot# 0000007268 and all of its subcomponents was completed and found that the device met its material, assembly and product specifications at the time of release to distribution.The review of the router and subsequent sub assembly routers did not highlight any anomalies.As of 25th august 2020, when the review was completed, there was no other complaint associated with lot number 0000007268, for the primary as reported failure zurpaz - patient - embolism, and for the secondary as reported failure zurpaz - patient - thrombus.From the information available, there is no evidence present to indicate that the device was not used per the directions for use/product label.Information printed on the inner and carton labels are accurate.Embolism and thrombus formation is an anticipated procedural complication and is a known physiological effect of the procedure as noted within the instructions for use.Following completion of creganna medical information review, the primary as analysed classification has been assigned zurpaz - product not returned - complaint unable to confirm and the secondary as analysed classification has been assigned zurpaz - n/a.There is no evidence of a potential processing or design failure associated with this complaint, no updates are required to the risk documentation for the zurpaz 8.5f steerable sheath device.The complaint is reportable.Based on the information available and a review of the risk documentation, there is a requirement to escalate this complaint to the quality management team at this time.A review of the complaint and event description was completed by creganna medical clinician.'embolic events are known complications of both atrial fibrillation as well as during/after ablation procedures to treat it.Many catheters and catheter repositioning occurs during these procedures so it is difficult to attribute this event to a specific device.It is just as likely that this is related to the underlying disease and potential conversion from atrial fibrillation to sinus rhythm.I would categorize this as either being related to the underlying disease or as a known complication of the procedure.'' following review of all information available the most probable investigation conclusion code assigned to this complaint is 'known inherent risk of device' defined as 'reported adverse event known and documented in the labelling (including both short or long term known complications or adverse reactions)'.As noted within the zurpaz device instructions for use embolism and thrombus formation is an anticipated procedural complication and is a known physiological effect of the procedure.Based on the above conclusion, no further escalation or corrective action is required at this time.We will continue to monitor for these complaint types.

Event Description

Complaint description received at creganna medical is as follows: event description: it was reported that: i would like to report an event that occurred during the procedure for atypical flutter treatment on (b)(6) 2020 at the (b)(6) hospital ((b)(6)).Post procedure, the patient reports an embolism event, probably due to the presence of a blood clot as reported by the physician.The event occurred not during the procedure but in the hours following it, but it is still necessary to report the event.Used materials: orion: ? gtin: (b)(4)? ref: m004rc64s0 ? lot: 24172873 intellanav mifi oi: ? gtin: 08714729938408 ? ref: m004epmr9620k20 ? lot: 24077210 zurpaz: ? gtin: (b)(4)? ref: m004eptmca85400 ? lot: 0000007268 plus, we used a competitor?s sheat, agilis (sjm), with ref: 407200 and lot: 7208576.Event date: (b)(6) 2020.

• Brand Name: ZURPAZ 8.5F STEERABLE SHEATH
• Type of Device: INTRODUCER STEERABLE
• Manufacturer (Section D): CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL; parkmore west; galway, H91 V N2T; EI H91 VN2T
• Manufacturer (Section G): CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL; parkmore west; galway, H91 V N2T; EI H91 VN2T
• Manufacturer Contact: mako sugimura ; parkmore west; galway, H91 V-N2T ; EI H91 VN2T
• MDR Report Key: 10448835
• MDR Text Key: 204393897
• Report Number: 3004193842-2020-00018
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: M004EPTMCA85400
• Device Lot Number: 0000007268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention