MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0605

Device Problem Difficult to Insert (1316)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Full event site name: (b)(6).Event site postal code: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.We are unable to confirm the reported event.If additional information is provided we will send a supplemental report with our additional findings.Reference complaint # (b)(4).Device was discarded and not returned.

Event Description

It was reported that during insertion of the intra aortic balloon (iab), the sheath was difficult to insert.There was no reported patient injury.

Manufacturer Narrative

Updated sections: adverse event/product problem, outcome attributed to ae, date of this report, describe event or problem ,date received by mfg,type of report,mfg follow-up #, if follow-up, what type, type of reportable event, patient codes.

Event Description

It was reported that during insertion of the intra aortic balloon (iab), the sheath was difficult to insert.There was no reported patient injury.Additional information has been received - prior to iabp therapy, the patient's general condition was reported to have been deteriorated already.After this insertion difficulty of the sheath occurred, the patient went into shock.Then the patient was treated with impella instead of iabp therapy.According to the physician, the relationship of this event to the patient's condition was unrelated.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10672874
• MDR Text Key: 211763281
• Report Number: 2248146-2020-00538
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2022
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000109197
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 10/18/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other