MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number CARDIAC UNKNOWN

Device Problems Difficult to Flush (1251); Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample not returning to manufacturer.

Event Description

It was reported via a hotline call from the registered nurse (rn) from the cicu they have a patient that had a non-fiberoptix intra-aortic balloon catheter (iab) in for 2-3 days.The central lumen has clotted.The rn had questions about how quickly the catheter should be removed and maintaining the central lumen.The clinical support specialist (css) explained that with any arterial line regardless of where it is, it should be removed as soon as possible.In the case of the iab, there are times that the patient may be too unstable to remove the balloon right away.In those cases, the central lumen should be capped and no manipulated to reduce the possibility of the clot moving forward into the aorta.The patient would have to be closely monitored for adverse symptoms.The css and rn discussed maintenance of the central lumen.The css asked if they had seen a lot of dampening with this central lumen.The rn said that it had a lot of whip.They were changing the transducer set-up and that's when it clotted off.The css explained on some patients, the central lumen of the catheter would have to be aspirated and flushed more frequently.The css and rn talked about how small and long the central lumen of the balloon catheter is.If there is more of a steep angle of insertion or tortuosity this can slow the constant flow from the transducer through the central lumen and dampen or clot the central lumen.The staff would need to troubleshoot and aspirate and flush the central lumen more frequently.The rn did say that they use heparinized saline in their iab flush solution.The rn said that the md was removing the catheter.The patient is stable and they were planning to remove the catheter anyway.There is no product for return.

Manufacturer Narrative

(b)(4).No product was returned for evaluation.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint of central lumen occluded is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported via a hotline call from the registered nurse (rn) from the cicu they have a patient that had a non-fiberoptix intra-aortic balloon catheter (iab) in for 2-3 days.The central lumen has clotted.The rn had questions about how quickly the catheter should be removed and maintaining the central lumen.The clinical support specialist (css) explained that with any arterial line regardless of where it is, it should be removed as soon as possible.In the case of the iab, there are times that the patient may be too unstable to remove the balloon right away.In those cases, the central lumen should be capped and no manipulated to reduce the possibility of the clot moving forward into the aorta.The patient would have to be closely monitored for adverse symptoms.The css and rn discussed maintenance of the central lumen.The css asked if they had seen a lot of dampening with this central lumen.The rn said that it had a lot of whip.They were changing the transducer set-up and that's when it clotted off.The css explained on some patients, the central lumen of the catheter would have to be aspirated and flushed more frequently.The css and rn talked about how small and long the central lumen of the balloon catheter is.If there is more of a steep angle of insertion or tortuosity, this can slow the constant flow from the transducer through the central lumen and dampen or clot the central lumen.The staff would need to troubleshoot and aspirate and flush the central lumen more frequently.The rn did say that they use heparinized saline in their iab flush solution.The rn said that the md was removing the catheter.The patient is stable and they were planning to remove the catheter anyway.There is no product for return.

• Brand Name: CARDIAC UNKNOWN DUMMY MATERIAL
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5973505
• MDR Text Key: 55477681
• Report Number: 1219856-2016-00216
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/28/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: CARDIAC UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1