MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) DREAMTOME¿ RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00584050

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that the packaging of a dreamtome rx 44 was compromised.According to the complainant, during unpacking, the sterile packaging was found to be torn.Reportedly, there was no damage noted to the shipping box.There was no procedure involved and the device was not used in the patient.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Visual examination revealed that the pouch of the device was damaged (ruptured).The seals do not have damages.The complaint was consistent with the reported event that the seal was compromised.It is the most likely that the handle (finger ring) caused the failure noted, therefore, the most probable cause of this complaint is handling damage, since it is the most likely that the complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that that the packaging of a dreamtome rx 44 was compromised.According to the complainant, during unpacking, the sterile packaging was found to be torn.Reportedly, there was no damage noted to the shipping box.There was no procedure involved and the device was not used in the patient.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: DREAMTOME¿ RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7166189
• MDR Text Key: 97104697
• Report Number: 3005099803-2017-03971
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729778271
• UDI-Public: 08714729778271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2020
• Device Model Number: M00584050
• Device Catalogue Number: 8405
• Device Lot Number: 21226679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• 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