MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT?; wire, guide, catheter

Model Number	H74938931010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was a 100% chronic total occlusion located in the severely tortuous and severely calcified right coronary artery (rca).A 185cm straight pt? guidewire was advanced into the lesion.During the procedure, the radiopaque tip of the guidewire was observed to have detached.The detached component did not migrate and remained lodged in the distal rca.No retrieval attempts were made due to the length of the procedure and cumulative radiation exposure.The physician determined that retrieval was not warranted.The patient remained stable throughout and after the procedure and was transferred to recovery in stable condition.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was a 100% chronic total occlusion located in the severely tortuous and severely calcified right coronary artery (rca).A 185cm straight pt? guidewire was advanced into the lesion.During the procedure, the radiopaque tip of the guidewire was observed to have detached.The detached component did not migrate and remained lodged in the distal rca.No retrieval attempts were made due to the length of the procedure and cumulative radiation exposure.The physician determined that retrieval was not warranted.The patient remained stable throughout and after the procedure and was transferred to recovery in stable condition.
Additional Manufacturer Narrative
Investigation results: device analysis finding: the device was not returned; therefore, a technical analysis could not be performed.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of adverse event related to patient condition, following a review of the reported event details, available information, and product record review, it is most likely the presence of reported anatomical factors, presented a constriction over the device and increase the friction when the device was advancing through the lesion reducing the mobility and generating the reported issue.Batch record review concluded that no manufacturing deviations were identified during the manufacturing process which could have contributed to the reported issue.To conclude, regarding the patient and impact codes of unretrieved device fragments (udf) and minor injury/ illness / impairment.The assigned cause code is adverse event related to patient condition since as a result of the constriction created over the wire, the distal tip detached, leaving a unretrieved portion of tip inside the patient, causing and minor injury, which can be attributable to factors that can occur during procedure with the use of the device.

• Brand Name: PT?
• Common Device Name: wire, guide, catheter
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25803803
• Report Number: 2124215-2026-37474
• Device Sequence Number: 12216615
• Product Code: DQX
• UDI-Device Identifier: 08714729471103
• UDI-Public: (01)08714729471103(17)280209(10)38559072
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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: H74938931010
• Device Catalogue Number: H74938931010
• Device Lot Number: 0038559072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 02/09/2026
• 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 Sex: Unknown