MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. CATERPILLAR EMBOLIZATION SYSTEM; ARTERIAL EMBOLIZATION DEVICE

Model Number	CTP056030U
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was not returned for evaluation.The result of the investigation is inconclusive for the reported failure to advance issue.A definite root cause could not be determined based upon the available information.Labeling review: the instruction for use for the caterpillar arterial embolization system was reviewed and contains the following information relevant to the reported event: precautions: verify that the delivery catheter that is used is compatible with the caterpillar¿ and caterpillar¿ micro arterial embolization devices prior to use.If excessive resistance beyond what would be expected is encountered at any point during advancement of the caterpillar¿ and caterpillar¿ micro arterial embolization devices through the delivery catheter, stop and remove the device and delivery catheter as one unit/together.(expiry date: 10/2021).
Event or Problem Description
It was reported through the results of a clinical trial that, during placement of an arterial embolization device, the study device allegedly failed to advance and the device plug didn't go forward.It was further reported that the subject was treated with a new device successfully.The patient reportedly experienced abdominal pain, however, the current status of patient is unknown.

• Brand Name: CATERPILLAR EMBOLIZATION SYSTEM
• Common Device Name: ARTERIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 11676553
• Report Number: 9616666-2021-00046
• Device Sequence Number: 11801641
• Product Code: KRD
• UDI-Device Identifier: 00801741175565
• UDI-Public: (01)00801741175565
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K191532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CTP056030U
• Device Catalogue Number: CTP056030U
• Device Lot Number: CMDY0371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR