MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA? II; CATHETER, PERCUTANEOUS

Model Number	H74939335150610
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.A 6f guidezilla guide extension catheter was selected for use.Upon unpacking, outside the patient, presence of foreign matter in the bag was observed.There were no complications and patient was stable post procedure.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).
Additional Manufacturer Narrative
Device analysis findings: device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device revealed that there was foreign material inside the sealed bag.Media attached to the parent record shows foreign material inside the pouch.No other issues were identified during the product analysis.Media review: during the analysis of the returned device, it was found foreign material inside the sealed bag, which confirms the reported allegation.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of manufacturing deficiency based on objective evidence obtained during product analysis.During the investigation, it was determined that the foreign material found inside the sealed bag most likely entered the package during the manufacturing process.E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device contamination occurred.A 6f guidezilla guide extension catheter was selected for use.Upon unpacking, outside the patient, presence of foreign matter in the bag was observed.There were no complications and patient was stable post procedure.

• Brand Name: GUIDEZILLA? II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24370066
• Report Number: 2124215-2026-08921
• Device Sequence Number: 4876627
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: (01)08714729939467(17)270529(10)36630916
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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
• Operator of Device: Health Professional
• Device Model Number: H74939335150610
• Device Catalogue Number: H74939335150610
• Device Lot Number: 0036630916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 65 KG