MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALLIANCE II; SYRINGE, BALLOON INFLATION

Model Number M00550601

Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)

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

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that an alliance syringe was intended to be used in the esophagus during an esophagogastroduodenoscopy (egd) performed on (b)(6) 2022.During preparation, the nurse manager went to restock alliance syringes and noticed the corrugated box was wet.Upon opening the alliance syringe packaging, it was noted to be wet and found that the syringes were also affected.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an alliance syringe was intended to be used in the esophagus during an esophagogastroduodenoscopy (egd) performed on (b)(6) 2022.During preparation, the nurse manager went to restock alliance syringes and noticed the corrugated box was soaked.Upon opening the alliance syringe packaging, it was noted to be wet and found that the syringes were also affected.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Correction it was noted that the sterile barrier of the device was compromised.The procedure was completed with another alliance syringe.

Manufacturer Narrative

Block h2: correction: blocks b5 (describe event or problem), d7a (sud reprocessed and reused), h6 (impact codes and device codes) h8 (usage of device), and h10 (additional mfr narrative) block h6: device code a020503 captures the reportable event of compromised sterility.

Event Description

It was reported to boston scientific corporation that an alliance syringe was intended to be used in the esophagus during an esophagogastroduodenoscopy (egd) performed on (b)(6) 2022.During preparation, the nurse manager went to restock alliance syringes and noticed the corrugated box was soaked.Upon opening the alliance syringe packaging, it was noted to be wet and found that the syringes were also affected.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Correction: it was noted that the sterile barrier of the device was compromised.The procedure was completed with another alliance syringe.

Manufacturer Narrative

Block h6: device code a020503 captures the reportable event of compromised sterility.Block h10: investigation results the returned alliance syringe was analyzed and a visual examination found that the box had a corner torn and a missing portion of it.The box also had stains of possible water damage.In the photos submitted by the customer it was possible to observe a wet stain on the boxes and the boxes damaged as well.The devices are sealed.With all the available information, boston scientific concludes that the torn corner found on the box and a missing portion of it are likely to have occurred due to factors encountered during shipment and/or storage.The tears may have occurred due to environmental factors during the transport or storage of the device, also an incorrect storage of the box, without the proper conditions could have induced the analyzed defects.Therefore, the most probable root cause is cause traced to transport/storage.

• Brand Name: ALLIANCE II
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15546161
• MDR Text Key: 306329789
• Report Number: 3005099803-2022-05777
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: 08714729129332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922573
• 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,Followup
• Report Date: 12/05/2022

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 Operator: Health Professional
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0029719423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 10/04/2022; 11/14/2022
• Supplement Dates FDA Received: 10/25/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• 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