MAUDE Adverse Event Report: CREGANNA MEDICAL TRAPPER¿ EXCHANGE DEVICE; BALLOON CATHETER

Catalog Number H74939330130

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2022

Event Type  malfunction  

Event Description

Ecn event description: when they opened the outside package they discovered that the pouch was not sealed and wasn't sterile.Patient present at time of event?: yes patient complications: no patient complications procedure date-unavailable per acct/cust device acquired from a distributor?: no.Event date: no value found.Note: based on the description of the incident and additional information received for this complaint patient was present at the time of the event however the device was not used in the procedure and there was no injury identified as a result of this event.The procedure was completed using an alternate device.

Manufacturer Narrative

The complaint reported has been assigned a primary as reported classification of trapper - packaging - pouch not sealed and a secondary as reported classification of trapper - n/a.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.A review of the lot specific manufacturing documentation could not be executed as the lot number is unknown.The distributor ran a ship history report on this customer and they identified 6 batches sold to this customer in the last 2 years.The dhr review on those 6 batches (since we can't be sure which batch was used) shipped to the customer has been completed.A ship history report brought up the following six batches sold to the customer: · 3571029508 (480 units were shipped to the distributor on 22 - sep-2021.) · 3571029749 (482 units were shipped to the distributor on 20 - oct-2021.) · 3571030857 (476 units were shipped to the distributor on 23 - mar-2022.) · 3571030858 (478 units were shipped to the distributor on 23 - mar-2022.) · 3571031081 (473 units were shipped to the distributor on 21 - apr-2022.) · 3571031612 (419 units were shipped to the distributor on 24 - aug-2022.) a review of the manufacturing documentation for lot# 3571029508; 3571029749; 3571030857; 3571030858; 3571031081; 3571031612 and all of their 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.A similar trend review could not be executed as the specific lot number is unknown.As of 12 december 2022, there were no other complaints associated with lot number 3571029508; 3571029749; 3571030857; 3571030858; 3571031081; 3571031612 for the primary as reported failure trapper - packaging - pouch not sealed.From the information available, there is no evidence present to indicate that the device was not used per the directions for use/product label.Trapper ifu includes the following instructions in relation to product sterility: warning section: ''contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.If damage is found, call your boston scientific representative.'' inspection prior to use: ''prior to intervention, carefully examine all equipment to be used during the procedure including the structural integrity of the device.Verify that the device and sterile packaging have not been damaged.Do not use if sterile package is damaged.'' following completion of creganna medical information review, the primary as analysed classification has been assigned trapper - product not returned - complaint unable to confirm and the secondary as analysed classification has been assigned trapper - 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 trapper device.The complaint is deemed reportable.Upon the above information, escalation is required to the quality management team.Therefore, after a full review of available information received the probable conclusion code classification assigned to this complaint is 'cause not established''.The definition of cause not established ' per our field complaint handling for legally manufactured product procedure is: ''the investigation findings do not lead to a clear conclusion about the cause of the report adverse event'.Creganna medical will err on the side of caution and is reporting this complaint to the fda as a mdr.We will continue to monitor for these complaint types.The initial complaint notification indicated that the complaint device will be returned.When we receive the complaint device for evaluation, any additional information is received, or we get a confirmation that the complaint device is not coming back, we will submit a follow-up report.B3.Date of event is unknown.Therefore we entered (b)(6) 2022 as a best estimated date.

Event Description

Ecn event description: when they opened the outside package they discovered that the pouch was not sealed and wasn't sterile.Patient present at time of event?: yes patient complications: no patient complications procedure date-unavailable per acct/cust.Device acquired from a distributor?: no.Event date: no value found.Note: based on the description of the incident and additional information received for this complaint patient was present at the time of the event however the device was not used in the procedure and there was no injury identified as a result of this event.The procedure was completed using an alternate device.

Manufacturer Narrative

Initial notification indicated that the device would come back.This follow-up 1 mdr is due to additional information received on 11-jan-2023.After multiple attempts were made to receive additional information and determine if the device was coming back, no response was received.Creganna medical have updated this mdr to reflect this new information.If more additional information is available or the device is returned, we will send another follow-up report.

• Brand Name: TRAPPER¿ EXCHANGE DEVICE
• Type of Device: BALLOON CATHETER
• Manufacturer (Section D): CREGANNA MEDICAL; parkmore west; galway, H91 V N2T; EI H91 VN2T
• Manufacturer (Section G): CREGANNA 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: 15987121
• MDR Text Key: 308559730
• Report Number: 3004193842-2022-00001
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K162253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: H74939330130
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/13/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other