MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO SLIM; HOLDER, NEEDLE, GASTROENTEROLOGIC

Model Number M0068318261

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

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2021, the date the bsc was first made aware of the event, as no event date was reported.The complainant was unable to provide the suspect device lot number; however, photos in the complaint email showed the device expiration date june 22, 2024.(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 on (b)(6) 2021, it was observed on the shelf that the capio slim device packaging was damaged.Reportedly, it was discovered on the shelf that the outer device box and the sterile packaging were damaged.Provided photos of the packaging showed the outer packaging and the sterile packaging were evidently crumpled, and there was a hole in the seal.There was no patient involved and there was no intended procedure.

• Brand Name: CAPIO SLIM
• Type of Device: HOLDER, NEEDLE, GASTROENTEROLOGIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12661004
• MDR Text Key: 277382962
• Report Number: 3005099803-2021-05297
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842804
• UDI-Public: 08714729842804
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• 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