MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00584040

Device Problems Contamination (1120); Packaging Problem (3007)

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

Event Date 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a dreamtome rx 44 was intended to be used in the common bile duct (cbd) in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During preparation outside the patient, when the device was unpacked, it was found that the packaging had water damage.Additionally, it was reported that there was not any other visible damage noted to the sterile pouch, seal, or the device itself.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and showed the device packaging had water damage which had infiltrated into the sterile pouch.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a1801 captures the reportable event of contaminated device due to water damage.Block h10: the returned dreamtome rx 44 was analyzed, and a visual evaluation noted that the jagtome mounting card had evidence of water damage on its surface.The device was observed under magnification and it does not have evidence of being used.Per media analysis, it was possible to observe that the pouch of the device had evidence of water damage on its surface.No other problems with the device were noted.The reported event of packaging damaged/defective was confirmed while the reported event device not sterile cannot be confirmed.Upon analysis, the jagtome mounting card had evidence of water damage on its surface.The reported event of device not sterile cannot be confirmed based on the provided picture alone and the pouch was not returned.The analyzed problem (jagtome mounting card damaged due to water interaction) is an issue that could have been generated by inappropriate storage conditions.Based on all gathered information, the most probable root cause of this complaint is cause traced to transport.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that this is the only complaint that exists for the specified lot.

Event Description

It was reported to boston scientific corporation that a dreamtome rx 44 was intended to be used in the common bile duct (cbd) in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2021.During preparation outside the patient, when the device was unpacked, it was found that the packaging had water damage.Additionally, it was reported that there was not any other visible damage noted to the sterile pouch, seal, or the device itself.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and showed the device packaging had water damage which had infiltrated into the sterile pouch.

• Brand Name: DREAMTOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12908356
• MDR Text Key: 286061575
• Report Number: 3005099803-2021-06338
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729778264
• UDI-Public: 08714729778264
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00584040
• Device Catalogue Number: 8404
• Device Lot Number: 0027584920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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