MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. UNKNOWN SAVVY LONG PTA DILATATION CATHETER

Catalog Number UNKNOWN SAVVY LONG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 03/01/2009

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported in an article vascular technique assessment titled, "staged angioplasty for carotid artery stenosis to prevent postoperative hyperperfusion" that some time post angioplasty and stent procedure the patient showed hyperperfusion phenomenon.Reportedly, the patient developed status epilepticus requiring sedation with intubation and mechanical ventilation for several days; resulting in permanent morbidity (dementia).

Manufacturer Narrative

After further review of article "staged angioplasty for carotid artery stenosis to prevent postoperative hyperperfusion" it was identified the reported product was a savvy product, manufactured by cordis, and not a savvy long product, manufactured by clearstream.Therefore, this event no longer meets the definition of a complaint per our internal processes and procedures since the device in question is not a bdpi product.As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported in an article vascular technique assessment titled, "staged angioplasty for carotid artery stenosis to prevent postoperative hyperperfusion" that some time post angioplasty and stent procedure the patient showed hyperperfusion phenomenon.Reportedly, the patient developed status epilepticus requiring sedation with intubation and mechanical ventilation for several days; resulting in permanent morbidity (dementia).

• Brand Name: UNKNOWN SAVVY LONG PTA DILATATION CATHETER
• Type of Device: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8434672
• MDR Text Key: 139291835
• Report Number: 9616666-2019-00025
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN SAVVY LONG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability